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Audumbar Mali ¹, Sujata Kolekar ², Jija Franklin ², Ritesh Bathe ¹

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, Raigad-410206, Maharashtra, IN

Abstract

Two simple, precise, economical, fast and reliable UV methods have been developed for the simultaneous estimation of Ranitidine 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 314 nm and 286 nm for Ranitidine and Domperidone respectively. Method B is area under curve (AUC), in the wavelength range of 269-340nm for Ranitidine and 262-307nm for Domperidone. Linearity for detector response was observed in the concentration range of 5-25μg/ml for Ranitidine and 5-25 μg/ml for Domperidone. The accuracy of the methods was assessed by recovery studies and was found to be 99.18% and 100.21% for Ranitidine and 100.19% and 101.57% 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 Ranitidine and Domperidone in commercial pharmaceutical dosage form.

Keywords

Ranitidine, Domperidone, Simultaneous Estimation, Precision, 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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