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Audumbar Mali ¹, Seeta Mali ², Ritesh Bathe ¹, Manojkumar Patil ¹, Ashpak Tamboli ²

Affiliations
1 Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN

Abstract

Simple, fast and reliable spectrophotometric methods were developed for determination of Riboflavin in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Methanol. The quantitative determination of the drug was carried out using the zero order derivative values measured at 445 nm and the area under the curve method values measured at 420-473nm (n=2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Riboflavin using 5-25μg/ml (r²=0.999 and r²=0.999) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Riboflavin in tablets.

Keywords

Riboflavin, UV Visible Spectrophotometry, AUC, Method Validation, Zero Order Method.

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Audumbar Mali ¹, Santosh Jadhav ¹, Rahul Gorad ², Aamer Quazi ², Ritesh Bathe ¹, Manojkumar Patil ¹, Ashpak Tamboli ³

Affiliations
1 Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN
2 Department of Pharmaceutics, ASPM’S K. T. Patil College of Pharmacy, Osmanabad-413501, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN

Abstract

Simple, precise, economical, fast and reliable two UV methods have been developed for the simultaneous estimation of Cefixime Trihydrate and Ofloxacin in bulk and pharmaceutical dosage form. Method A is Absorbance maxima method, which is based on measurement of absorption at maximum wavelength of 287 nm and 296 nm for Cefixime Trihydrate and Ofloxacin respectively. Method B is area under curve (AUC), in the wavelength range of 265-301 nm for Cefixime Trihydrate and277-320nm for Ofloxacin. Linearity for detector response was observed in the concentration range of 5-25 μg/ml for Cefixime Trihydrate and 5-25 μg/ml for Ofloxacin. The accuracy of the methods was assessed by recovery studies and was found to be 98.83% and 100.12% for Cefixime Trihydrate and 102.71 % and 99.01 % Ofloxacin by using method A and B respectively. The developed method was validated with respect to linearity, accuracy (recovery), precision and specificity. The results were validated statistically as per ICH Q2 R1guideline and were found to be satisfactory. The proposed methods were successfully applied for the determination of for Cefixime Trihydrate and Ofloxacin in commercial pharmaceutical dosage form.

Keywords

Cefixime Trihydrate, Ofloxacin, Simultaneous Estimation, Accuracy, Absorbance Maxima Method, Area under Curve.

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Audumbar Mali ¹, Sujata Kolekar ², Jeeja Panachery ³, Ashpak Tamboli ⁴

Affiliations
1 Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN
2 Department of Quality Assurance, Shri D.D. Vispute college of Pharmacy and Research Centre, Devad-Vichumbe, New Panvel, Mumbai, Maharashtra, IN
3 Department of Pharmacognosy and Phytochemistry, Shri D.D. Vispute college of Pharmacy and Research Centre, Devad-Vichumbe, New Panvel, Mumbai, Maharashtra, IN
4 Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN

Abstract

Derivative spectrophotometry offers a useful approach for the analysis of drugs in multi-component formulation. In this study a first order derivative spectrophotometric method is applied for the simultaneous determination of Paracetamol and Domperidone in Tablet dosage form. The measurements were carried out at wavelengths of 262 and 297 nm for Paracetamol and Domperidone respectively. The method was found to be linear (r²=0.999) in the range of 5-25 μg/ml for Paracetamol in the presence of 20μg/ml of Domperidone at 262 nm. The linear correlation (r²=0.999) was obtained in the range of 5-25μg/ml for Domperidone in the presence of 20μg/ml of Paracetamol at 297 nm. The method was successfully used for simultaneous determination of Paracetamol and Domperidone in tablet dosage form without any interference from excipients and prior separation.

Keywords

Paracetamol, Domperidone, UV Visible Spectrophotometry, Method Validation, First Order Derivative Method.

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Audumbar Digambar Mali ¹, Ritesh Bathe ¹, Ashpak Tamboli ²

Affiliations
1 Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN

Abstract

Simple, fast and reliable spectrophotometry methods were developed for determination of Domperidonein bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Methanol. The quantitative determination of the drug was carried out using the zero order derivative values measured at 286nm and the area under the curve method values measured at 279-293 nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Domperidone using 5-25μg/ml (r²=0.999 and r²=0.998) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Domperidonein tablets.

Keywords

Domperidone, UV Visible Spectrophotometry, AUC, Method Validation, Precission, Accuracy.

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Audumbar Mali ¹, Rahul Gorad ², Aamer Quazi ², Ritesh Bathe ¹, Ashpak Tamboli ³

Affiliations
1 Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN
2 Department of Pharmaceutics, ASPM’S K. T. Patil College of Pharmacy, Osmanabad-413501, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN

Abstract

Simple, novel, fast, accurate and reliable spectrophotometric methods were developed for determination of Pyridoxine HCl in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Dist. water. The quantitative determination of the drug was carried out using the second order Derivative Area under Curve method values measured at 301-319nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Pyridoxine HCl using 5-25μg/ml (r²=0.9966) for second order derivative Area under Curve spectrophotometric method. The proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of Pyridoxine HCl in pharmaceutical formulations.

Keywords

Pyridoxine HCI, Second Order Derivative, Area under Curve (AUC), Precision, Accuracy.

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Audumbar Mali ¹, Ankush Hake ², Manoj Patil ², Ritesh Bathe ¹, Ashpak Tamboli ³

Affiliations
1 Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, IN

Abstract

Two simple, precise, economical, fast and reliable UV methods have been developed for the simultaneous estimation of Paracetamol and Domperidone in bulk and pharmaceutical dosage form. Method A is Absorbance maxima method, which is based on measurement of absorption at maximum wavelength of 248 nm and 286 nm for Paracetamol and Domperidone respectively. Method B is area under curve (AUC), in the wavelength range of 220-274 nm for Paracetamol and 262-304 nm for Domperidone. Linearity for detector response was observed in the concentration range of 5-25 μg/ml for Paracetamol and 5-25 μg/ml for Domperidone. The accuracy of the methods was assessed by recovery studies and was found to be 100.11 % and 102.04 % for Paracetamol and 99.10 % and 100.52 % Domperidone by using method A and B respectively. The developed method was validated with respect to linearity, accuracy (recovery), precision and specificity. The results were validated statistically as per ICH Q2 R1guideline and were found to be satisfactory. The proposed methods were successfully applied for the determination of for Paracetamol and Domperidone in commercial pharmaceutical dosage form.

Keywords

Paracetamol, Domperidone, Simultaneous Estimation, Area under Curve, Precision, Absorbance Maxima Method.

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