Informatics Publishing Limited

Krishna V. Prajapati ¹, Hasumati A. Raj ¹, Vineet C. Jain ¹

Affiliations
1 Shree Dhanvantary College of Pharmacy, Kim, Surat, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Mesalazine and Rifaximin in synthetic mixture using Simultaneous Equation Method. The absorbance was measured at 328 nm for Mesalazine and 292nm for Rifaximin and calibration curves were plotted as absorbance versus concentration, respectively. The method was found to be linear (r²> 0.999) in the range of10-50 μg/ml for Mesalazine at 328nm. The linear correlation was obtained (r²> 0.999) in the range of 10-50 μg/ml for Rifaximin at 292nm. The limit of determination (LOD) was 0.215μg/ml and 0.214μg/ml for Mesalazine and Rifaximin respectively. The limit of quantification (LOQ) was 0.652μg/ml and 0.648 μg/ml for Mesalazine and Rifaximin respectively. The accuracy of this method was evaluated by recovery studies and good recovery results were obtained greater than 99%.The method was successfully applied for simultaneous determination of Mesalazine and Rifaximin in binary mixture.

Keywords

Mesalazine, Rifaximin, Simultaneous Estimation, Simultaneous Equation Method.

Full Text

     

Pranali S. Sisode ¹, Hasumati A. Raj ¹, Vineet C. Jain ²

Affiliations
1 Department of Quality Assurance, Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat, IN
2 Department of Pharmacognosy, Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Saxagliptin Hydrochloride and Glibenclamide in synthetic mixture using first order derivative zero-crossing method. Saxagliptin Hydrochloride showed zero crossing point at 315.00nm while Glibenclamide showed zero crossing point at 229.40nm. The dA/dλ was measured at 229.40nm for Saxagliptin Hydrochloride and 315.00nm for Glibenclamide and calibration curves were plotted as dA/dλ versus concentration, respectively. The method was found to be linear (r2>0.9995) in the range of 5-25μg/ml for Saxagliptin Hydrochloride at 229.40nm. The linear correlation was obtained (r2>0.9994) in the range of 5-25 μg/ml for Glibenclamide at 315.00nm. The limit of determination was 0.243μg/ml and 0.317μg/ml for Saxagliptin Hydrochloride and Glibenclamide, respectively. The limit of quantification was 0.738μg/ml and 0.960μg/ml for Saxagliptin Hydrochloride and Glibenclamide respectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99% shows first order derivation zero crossing. The method was successfully applied for simultaneous determination of Saxagliptin Hydrochloride and Glibenclamide in binary mixture.

Keywords

Saxagliptin Hydrochloride, Glibenclamide, First Derivative Method, Spectroscopic Method.

Full Text

     

Pooja A. Patil ¹, Hasumati A. Raj ¹, Gautam B. Sonara ²

Affiliations
1 Department of Quality Assurance, Shree Dhanvantary Pharmacy College, Kim, Dist: Surat, Gujarat, IN
2 Department of Quality Assurance , Gujarat Technological University, Vishvkarma Road, Chandkheda, ONGC Circle, Ahmadabad 394110, IN

Abstract

A simple, accurate, precise, economic, robust and rugged UV spectrophotometric method has been developed for the simultaneous estimation of Atenolol and Ivabradine HCl in synthetic mixture. Combination of Atenolol and Ivabradine HCl has not any analytical method developed yet, so this UV method is novel for combined synthetic dosage of Atenolol and Ivabradine HCl (10:1). The absorbance maxima of Atenolol and Ivabradine HCl were found to be 276.00 nm and 286.50 nm respectively. Beer law obeyed the concentration range of 20-100 μg/ml and 2-10 μg/ml for Ivabradine HCl. The result of analysis was validated statistically and by the recovery studies. The %RSD value of all validation parameter less than 2. The proposed method can be effectively applied for the estimation of these two drugs.

Keywords

UV Spectrophotometry, Atenolol, Ivabradine HCl, Simultaneous Method.

Full Text

     

Vishakha D. Patel ¹, Hasumati A. Raj ¹, Nirav K. Gheewala ¹

Affiliations
1 Shree Dhanvantary College of Pharmacy, Kim, Surat, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Amiodarone Hydrochloride and Ranolazine in synthetic mixture using Second order derivative zero-crossing method. Amiodarone HCl showed zero crossing point at 249.20 nm while Ranolazine showed zero crossing point at 263.20 nm. The dA/dλ was measured at 263.20 nm for Amiodarone HCl and 249.20 nm for Ranolazine and calibration curves were plotted as 2dA/2dλ versus concentration, respectively The linear correlation was obtained (r²>0.9996) in the range of 1-20 μg/ml for Amiodarone HCl at 263.20 nm. The method was found to be linear (r²>0.9996) in the range of 10-200 μg/ml for Ranolazine 249.20 nm. The limit of determination was 0.235μg/ml and 0.271μg/ml for Amiodarone HCl and Ranolazine, respectively. The limit of quantification was 0.712μg/ml and 0.823μg/ml for Amiodarone HCl and Ranolazine, respectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99% shows Second order derivation zero crossing. The method was successfully applied for simultaneous determination of Amiodarone HCl and Ranolazine in binary mixture.

Keywords

Amiodarone HCl, Ranolazine, Second Derivative Method, Spectroscopic Method.

Full Text

     

Rucha A. Patel ¹, Meghna P. Patel ¹, Hasumati A. Raj ¹, Nehal Shah ²

Affiliations
1 Department of Quality Assurance, Shree Dhanvantry Pharmacy College, Kim, Surat, Gujarat, IN
2 Dharmaj Degree of Pharmacy, Dharmaj, Anand, Gujarat, IN

Abstract

The proposed study describes an isocratic reversed phase HPLC method for investigation of degradation products of Olmesartan medoxomil API under different stress conditions (acid hydrolysis degradation). Separation of Olmesartan medoxomil and its degradation products was achieved on symmetry C₁₈ (150 mm × 4.6 mm, 5 μ) column using a Acetonitrile: 0.02 M Na₂HPO₄(45:55 v/v) mobile phase and pH 7 adjusted with ortho phosphoric acid. Isocratic elution mode at a flow rate of 1.0 ml/min at Room temperature with a load of 20μl Injection volume. The detection was carried out at 240 nm followed by Base hydrolysis Structures of the degradation products were studied using a Triple Quadrapole Mass Spectrometer. A separate gradient LCMS method was developed for this purpose Depending on the degradation type, possible chemical reactions were predicted and supported by fragmentation data obtained from LC-MS/NMR. One major products were obtained in solid form using Rotavap and were then analyzed by NMR, IR and TLC to confirm their structural details.

Keywords

Olmesartan Medoxomil, Forced Degradation Studies, Degradation Products, LC, LCMS,NMR, IR and TLC.

Full Text

     

Monika A. Rana ¹, Hasumati A. Raj ²

Affiliations
1 Department of Quality Assurance, Shree Dhanvantary Pharmacy College, Kim Surat, Gujarat, IN
2 Department of Quality Assurance, Shree Dhanvantary Pharmacy College, Kim Surat, Gujarat

Abstract

A simple, accurate and precise spectroscopic method was developed for Levosulpiride and 2-methoxy 5- sulfamoylbenzoyl benzoic acid methyl ester in synthetic mixture using Q absorbance Ratio Method. In this spectroscopic method, 231.50 nm (as an iso-absorptive point) and 240.60 nm wavelengths (λmax of any of the two drugs) were selected for measurement of absorptivity. Both the drugs show linearity in a concentration range of 10-30 μg/ml at their respective λmax and at the isoabsorptive point. The relative standard deviation for accuracy, precision studies were found to be within the acceptance range (<2%). The limit of determination was 0.084μg/ml and 0.110μg/ml for Levosulpiride and 2-methoxy 5-sulfamoylbenzoyl benzoic acid methyl ester, respectively. The limit of quantification was 0.257μg/ml and 0.330 μg/ml for Levosulpiride and2-methoxy 5-sulfamoylbenzoyl benzoic acid methyl ester, respectively. Recovery of Levosulpiride and 2-methoxy 5-sulfamoylbenzoyl benzoic acid methyl ester were found to be 101.12 % and 101.89 % respectively confirming the accuracy of the proposed method. The proposed method is recommended for routine analysis since they are rapid, simple, accurate and also sensitive and specific by no heating and no organic solvent extraction.

Keywords

Levosulpiride, 2-Methoxy 5-Sulfamoylbenzoyl Benzoic Acid Methyl Ester, Q Absorbance Ratio Method.

Full Text

     

Priyanka P. Atodariya ¹, Hasumati A. Raj ¹, Vineet C. Jain ¹

Affiliations
1 Shree Dhanvantary Pharmacy Collage, Kim, Surat, Gujarat, IN

Abstract

Two simple spectroscopic methods have been developed for simultaneous estimation of Lamotrigine and Clozapine in synthetic mixture. Simultaneous equation method involves the measurement of absorption at two wavelengths 308 nm (λmax for Lamotrigine) and 259.60 nm (λmax for Clozapine). The method was found linear between the range of 1-5 μg/ml for Lamotrigine and 6-30 μg/ml for Clozapine for method .The accuracy and precision was determined and validated statistically. Both the method showed good reproducibility and recovery with %RSD less than 1.The method was found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis for Lamotrigine and Clozapine in bulk and combined dosage form.

Keywords

Lamotrigine, Clozapine, Simultaneous Equation Method.

Full Text

     

Farhana V. Buchiya ¹, Ashif I. Bhim ¹, Hasumati A. Raj ¹, Vineet C. Jain ²

Affiliations
1 Department of Quality Assurance, Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat, IN
2 Department of Pharmacognosy, Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimationof Cilnidipine and Valsartan in synthetic mixture using Simultaneous Equation Method. The absorbance was measured at 240.00nm for Cilnidipine and 250.00nm for Valsartan and calibration curves were plotted as absorbance versus concentration, respectively. The method was found to be linear (r²>0.999) in the range of 2-10μg/ml for Cilnidipine at 240.00nm. The linear correlation was obtained (r²>0.999) in the range of 16-80μg/ml for Valsartan at 250.00nm. The limit of determination (LOD) was 0.07 μg/ml and 0.266μg/ml for Cilnidipine and Valsartan respectively. The limit of quantification (LOQ) was 0.22μg/ml and 0.808μg/ml for Cilnidipine and Valsartan respectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99%.The method was successfully applied for simultaneous determination of Cilnidipine and Valsartan in binary mixture.

Keywords

Cilnidipine, Valsartan, Simultaneous Estimation, Simultaneous Equation Method.

Full Text

     

Rucha A. Patel ¹, Meghna P. Patel ¹, Hasumati A. Raj ¹, Nehal Shah ²

Affiliations
1 Department of Quality Assurance, Shree Dhanvantry Pharmacy College, Kim, Surat, Gujarat, IN
2 Dharmaj Degree of Pharmacy, Dharmaj, Anand, Gujarat, IN

Abstract

An approach of forced degradation study was successfully applied for the development of a stability-indicating high performance liquid chromatographic method for simultaneous determination of Olmesartan medoxomil and Indapamide in a formulation in the presence of its degradation products. In the present study a simple, accurate and precise reverse phase liquid chromatographic method has been developed and validated for simultaneous estimation of Olmesartan medoxomil and Indapamide in tablet dosage form. Developed Method was achieved on symmetry C₁₈ (150 mm × 4.6 mm, 5 μ) column using a Acetonitrile: 0.02 M Na₂HPO₄ (45:55 v/v) mobile phase and pH 7 adjusted with ortho phosphoric acid. Isocratic elution mode at a flow rate of 1.0 ml/min at Room temperature with a load of 20μl Injection volume. The detection was carried out at 240 nm. The linearity of the proposed method was investigated in the range of 50-250 microg/mL (r² = 0.998) for Olmesartan medoxomil and 10-50 microg/mL (r² = 0.998) for Indapamide. The retention time of Olmesartan medoxomil and Indapamide were found to be around 4.79 min and 7.59 min respectively. The drug substances were subjected to stress conditions of acid hydrolysis, base hydrolysis, Oxidative, photolytic and thermal. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision, robustness, LOD and LOQ.

Keywords

Olmesartan Medoxomil, Indapamide, Hypertension, Stability Study.

Full Text

     

Vandana M. Patel ¹, Hasumati A. Raj ¹, Vineet C. Jain ¹

Affiliations
1 Department of Quality Assurance, Shree Dhanvantary College of Pharmacy, Kim, Surat, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Amlodipine besylate and Simvastatin in synthetic mixture using Absorbance correction method. At 360.80 nm (λmax of Amlodipine besylate) Simvastatin has zero absorbance so Amlodipine besylate is directly estimate at 360.80 nm. At 237.60 nm (λmax of Simvastatin) both drugs have some absorbance so Simvastatin is estimate at 237.60 nm using absorbance correction method.The method was found to be linear (r2>0.999) in the range of 5-10 μμg/ml for Amlodipine besylate at 360.80 nm. The linear correlation was obtained (r2>0.999) in the range of 5-10 μg/ml for Simvastatin at 237.60 nm. The limit of determination was 0.17 μg/ml and 0.10 μg/ml for Amlodipine besylate and Simvastatin, respectively. The limit of quantification was 0. 54μg/ml and 0. 32μg/ml for Amlodipine besylate and Simvastatin, respectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99%. The method was successfully applied for simultaneous determination of Amlodipine besylate and Simvastatin in binary mixture.

Keywords

Amlodipine Besylate, Simvastatin, Absorption Correction Method.

Full Text

     

Bhavisha G. Patel ¹, Nirav Gheewala ¹, Hasumati A. Raj ¹

Affiliations
1 Shree Dhanvantary College of Pharmacy, Kim, Surat, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Lidocaine Hydrochloride and Clotrimazole in Ear Drop by Advance simultaneous equation method. A zero order spectrum was recorded and convert in ratio second order derivative. The Lidocaine Hydrochloride shows max absorbance at 243.20 nm and Clotrimazole show max absorbance at 225 nm. The method was found to be linear (r²>0.999) in the concentration range of 20-100 μg/ml for Lidocaine Hydrochloride and 10-50 μg/ml for Clotrimazole. The limit of determination was 0.2498 μg/ml and 0.0837 μg/ml for Lidocaine Hydrochloride and Clotrimazole, respectively. The limit of quantification was 0.7570 μg/ml and 0.2537 μg/ml for Lidocaine Hydrochloride and Clotrimazole, respectively. The accuracy of this method was evaluated by recovery studies and good recovery result was obtained greater than 99%. The method was successfully applied for simultaneous determination of Lidocaine Hydrochloride and Clotrimazole in Ear Drop.

Keywords

Lidocaine Hydrochloride, Clotrimazole and Advance Simultaneous Equation Method.

Full Text

     

Tabassum H. Aaraf ¹, Hasumati A. Raj ¹, Vineet C. Jain ¹, Vishnu Sutariya ²

Affiliations
1 Shree Dhanvantary College of Pharmacy, Kim, Surat, Gujarat, IN
2 Shree Dhanvantary Pharmaceutical Analysis & Research Centre, Kim, Surat, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Metronidazole Benzoate and related impurity in bulk and pharmaceutical formulation by ratio derivative simultaneous equation method. The method is based on dividing the spectrum for a mixture into the standard spectra for each of the analysis and to obtain a spectrum that is independent of the analyte concentration used as a divisor. In this method for MND, MNI and BA the linearity range 2.0-10 μg/ml were divided by the divisor 2.0 μg/ml of MTZ. The use of standardized spectra as divisors minimizes experimental errors. Ratio spectra derivative permits the use of the wavelengths corresponding to maximum or minimum and also the use of the distance between consecutive maximum and minimum. For that the divided spectra was converted to second derivative using DL value 16 and SF value 100. The Metronidazole shows max absorbance at 270.00 nm, 2- Methyl-5Nitroimidazole show max absorbance at 257.42 nm and Benzoic Acid shows max. absorbance at 245.61 nm. The method was found to be linear (r2>0.997) in the range of 2.0-10 μg/ml. The limit of determination was 0.049 μg/ml and 0.026 μg/ml and0.038 μg/ml for Metronidazole, 2-Methyl-5-Nitroimidazole and Benzoic Acid, respectively. The limit of quantification was 0.150 μg/ml and 0.079 μg/ml and 0.115 μg/ml for Metronidazole, 2-Methyl-5-Nitroimidazole and Benzoic Acid, respectively. The accuracy of this method was evaluated by recovery studies and good recovery result was obtained 100%. The method was successfully applied for simultaneous determination of Metronidazole, 2-Methyl-5-Nitroimidazole and Benzoic Acid.

Keywords

Metronidazole Benzoate, Metronidazole, 2-Methyl-5-Nitroimidazole, Benzoic Acid, Ratio Derivative Simultaneous Equation Method.

Full Text

     

Grishma S. Trivedi ¹, Hasumati A. Raj ¹, Vineet C. Jain ¹

Affiliations
1 Shree Dhanvantary College of Pharmacy, Kim, Surat, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Pravastatin and Valsartan in synthetic mixture using first order derivative zero-crossing method. Pravastatin showed zero crossing point at 262.40 nm while Valsartan showed zero crossing point at 248.20 nm. The dA/dλ was measured at 248.20 nm for Pravastatin and 262.80 nm for Valsartan and calibration curves were plotted as dA/dλ versus concentration, respectively. The method was found to be linear (r2>0.999) in the range of 2-10μg/ml for Pravastatin at 248.20 nm. The linear correlation was obtained (r2>0.9998) in the range of 8-40μg/ml for Valsartan at 262.40 nm. The limit of determination was 0.054μg/ml and 0.024μg/ml for Pravastatin and Valsartan, respectively. The limit of quantification was 0.166μg/ml and 0.074μg/ml for Pravastatin and Valsartan, respectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99% shows first order derivation zero crossing. The method was successfully applied for simultaneous determination of Pravastatin and Valsartan in binary mixture.

Keywords

Pravastatin, Valsartan, First Derivative Method, Spectroscopic Method.

Full Text

     

Monika A. Rana ¹, Hasumati A. Raj ¹

Affiliations
1 Department of Quality Assurance, Shree Dhanvantary Pharmacy College, Kim Surat, Gujarat, IN

Abstract

A simple, accurate and precise chromatography method was developed for Levosulpiride and 2-methoxy 5- sulfamoylbenzoyl benzoic acid methyl ester in synthetic mixture using RP-HPLC Method. In this chromatography method, both drug show its peak at 232 nm. Both the drugs show linearity in a concentration range of 10-50 μg/ml at their respective λmax. Optimize Mobile Phase was Water : Methanol : Acetonitrile (70 : 15 : 15). The relative standard deviation for accuracy, precision studies were found to be within the acceptance range (<2%). The limit of determination was 0.14μg/ml and 0.19μg/ml for Levosulpiride and 2-methoxy 5- sulfamoylbenzoyl benzoic acid methyl ester, respectively. The limit of quantification was 0.42μg/ml and 0.59μg/ml for Levosulpiride and 2-methoxy 5-sulfamoylbenzoyl benzoic acid methyl ester, respectively. Recovery of Levosulpiride and 2-methoxy 5-sulfamoylbenzoyl benzoic acid methyl ester were found to be 100.16 % and 99.15 % respectively confirming the accuracy of the proposed method. The proposed method is recommended for routine analysis since they are rapid, simple, accurate and also sensitive and specific by no heating and no organic solvent extraction.

Keywords

Levosulpiride, 2-Methoxy 5-Sulfamoylbenzoyl Benzoic Acid Methyl Ester, RP-HPLC Method.

Full Text

     

Divya A. Patel ¹, Hasumati A. Raj ¹, Vineet C. Jain ¹

Affiliations
1 Shree Dhanvantary College of Pharmacy, Kim, Surat, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Edaravone and Argatroban in synthetic mixture using first order derivative zero-crossing method. Edaravone showed zero crossing point at 351.00 nm while Argatroban showed zero crossing point at 280.47 nm. The dA/dλ was measured at 280.47 nm for Edaravone and 351.00nm for Argatroban and calibration curves were plotted as dA/dλ versus concentration, respectively. The method was found to be linear (r2>0.998) in the range of 10-35μg/ml for Edaravone at 280.47 nm. The linear correlation was obtained (r2>0.999) in the range of 10-35 μg/ml for Argatroban at 351.0 nm. The limit of determination was 1.59μg/ml and 1.87μg/ml for Edaravone and Argatroban, respectively. The limit of quantification was 4.83 μg/ml and 5.68 μg/ml for Edaravone and Argatroban, respectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99% shows first order derivation zero crossing. The method was successfully applied for simultaneous determination of Edaravone and Argatroban in binary mixture.

Keywords

Edaravone, Argatroban , First Derivative Method, Spectroscopic Method.

Full Text

     

Grishma S. Trivedi ¹, Meera V. Lad ¹, Hasumati A. Raj ¹

Affiliations
1 Shree Dhanvantary College of Pharmacy, Kim, Surat, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Edaravone and Argatroban in synthetic mixture using first order derivative zero-crossing method. Edaravone showed zero crossing point at 351.00 nm while Argatroban showed zero crossing point at 280.47 nm. The dA/dλ was measured at 280.47 nm for Edaravone and 351.00nm for Argatroban and calibration curves were plotted as dA/dλ versus concentration, respectively. The method was found to be linear (r2>0.998) in the range of 10-35μg/ml for Edaravone at 280.47 nm. The linear correlation was obtained (r2>0.999) in the range of 10-35 μg/ml for Argatroban at 351.0 nm. The limit of determination was 1.59μg/ml and 1.87μg/ml for Edaravone and Argatroban, respectively. The limit of quantification was 4.83 μg/ml and 5.68 μg/ml for Edaravone and Argatroban, respectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99% shows first order derivation zero crossing. The method was successfully applied for simultaneous determination of Edaravone and Argatroban in binary mixture.

Full Text

     

Divya A. Patel ¹, Hasumati A. Raj ¹, Vineet C. Jain ¹

Affiliations
1 Shree Dhanvantary College of Pharmacy, Kim, Surat, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Edaravone and Argatroban in synthetic mixture using Absorbance correction method. At 333 nm (λmax of Argatroban) Edaravone has zero absorbance so Argatroban is directly estimate at 333 nm. At 242 nm (λmax of Edaravone) both drugs have some absorbance so Edaravone is estimate at 242 nm using absorbance correction method.

The method was found to be linear (r2>0.992) in the range of 10-35μg/ml for Edaravone at 242 nm. The linear correlation was obtained (r2>0.998) in the range of 10-35 μg/ml for Argatroban at 333 nm. The limit of determination was 0.060 μg/ml and 0.208μg/ml for Edaravone and Argatroban, respectively. The limit of quantification was 0.184μg/ml and 0.631μg/ml for Edaravone and Argatroban, respectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99%. The method was successfully applied for simultaneous determination of Edaravone and Argatroban in binary mixture.

Keywords

Edaravone, Argatroban, Absorbance Correction Method, Spectroscopic Method.

Full Text

     

Pooja A. Patil ¹, Hasumati A. Raj ¹, Gautam B. Sonara ²

Affiliations
1 Department of Quality Assurance, Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat, IN
2 Department of Pharmacognosy, Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat, IN

Abstract

It describes Simultaneous estimation of simple, accurate, precise, robust and economical Q-Absorbance ratio spectrophotometric method for Atenolol and Ivabradine HCl in synthetic mixture.

Objective: To Delivered information related to Ivabradine HCl and Atenolol combination's analytical method. Both drugs in combination have not any analytical method done by other or nor published anywhere. So we developed and validated it which is novel method for drugs.

Method: Absorbance ratio method for the ratio of absorbance at two selected wavelengths, one which is an isoabsorbtive point and other being the λ-max of one of the two component. Atenolol and Ivabradine HCl show an iso-absorbtive point at 286.40nm in methanol. The second wavelength used is 276nm which is λ-max of Atenolol in methanol. So it is economic in nature. The linearity was obtained in the concentration range of 20-100μg/ml for Atenolol and 2-10μg/ml for Ivabradine HCl. The concentration of the drugs was determined by using ratio of absorbance at iso-absorbtive point and at the λ-max of Atenolol.

Result: This method is linear for both drugs; in range 2-10μg/ml for Ivabradine HCl and 20-100μg/ml for Atenolol found at λmax of Atenolol 276nm (R²=0.9990) and at Iso-absorptive point 286.40nm (R²=0.9998). % recovery for Ivabradine HCl found 100.47% and Atenolol 100.32%. And all validation parameter (Robustness, Ruggedness, Interday, Intraday) show %RSD >2%. And Limit of detection for Ivabradine HCl and Atenolol at λ₁(maximum wavelength) and λ₂(Iso-absorptive point) was found 0.309 and 0.181 respectively. % Assay for Ivabradine HCl and Atenolol found to be 100.58% and 100.13% respectively.

Conclusion: The method was successfully applied to pharmaceutical synthetic mixture which is considered in approved patent which show no interference. The result of analysis has been validated statistically and by recovery studies. So this method accurate, precise, robust, rugged and economic in nature.

Keywords

Atenolol, Ivabradine HCl, Absorbance Ratio Method, Iso-Absorbtivepoint.

Full Text

     

Rucha A Patel ¹, Meghna P. Patel ¹, Hasumati A. Raj ¹, Nehal Shah ²

Affiliations
1 Department of Quality Assurance, Shree Dhanvantry Pharmacy College, Kim, Surat, Gujarat, IN
2 Dharmaj Degree of Pharmacy, Dharmaj, Anand, Gujarat, IN

Abstract

An approach of forced degradation study was successfully applied for the development of a stability-indicating high performance liquid chromatographic method for simultaneous determination of Olmesartan medoxomil and Indapamide in a formulation in the presence of its degradation products. In the present study a simple, accurate and precise reverse phase liquid chromatographic method has been developed and validated for simultaneous estimation of Olmesartan medoxomil and Indapamide in tablet dosage form. Developed Method was achieved on symmetry C18 (150 mm × 4.6 mm, 5 μ) column using a Acetonitrile: 0.02 M Na2HPO4(45:55 v/v) mobile phase and pH 7 adjusted with ortho phosphoric acid. Isocratic elution mode at a flow rate of 1.0 ml/min at Room temperature with a load of 20μl Injection volume. The detection was carried out at 240 nm. The linearity of the proposed method was investigated in the range of 50-250 microg/mL (r2 = 0.998) for Olmesartan medoxomil and 10-50 microg/mL (r2 = 0.998) for Indapamide. The retention time of Olmesartan medoxomil and Indapamide were found to be around 4.79 min and 7.59 min respectively. The drug substances were subjected to stress conditions of acid hydrolysis, base hydrolysis, Oxidative, photolytic and thermal. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision, robustness, LOD and LOQ.

Keywords

Olmesartan Medoxomil, Indapamide, Hypertension, Stability Study.

Full Text