Asian Journal of Pharmacy and Technology

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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