Asian Journal of Pharmaceutical Analysis

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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