Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF DOMPERIDONE AND PANTOPRAZOLE SODIUM IN BULK AND PHARMACEUTICAL DOSAGE FORM

Kaveri Chandrakant Dulange*, Dr. Mallinath Shankarappa Kalshetti, Neha Ranjeet Gate, Shubhangi Sidram Bamgonde, Zeba Mahamad Hanif Gaibu

ABSTRACT

A simple, rapid, precise and highly selective spectrophotometric method was developed for simultaneous estimation of Domperidone and Pantoprazole sodium in pure as well as tablet dosage form. The simultaneous equation method is based on measurement of absorbance at 288 nm and 291 nm as two wavelengths selected for quantification of Domperidone and Pantoprazole sodium using methanol as a solvent. The method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness. A double-beam shimadzu UV-visible spectrophotometer, 1800 with a pair of 1 cm matched quartz cells was used to measure the absorbance of the solutions in developed method. The method was validated as per ICH guidelines. Linearity ranges from 5-25 μg/ml for Domperidone and 5-25 μg/ml for Pantoprazole of the drugs. % RSD calculated was less than equal to 2 which indicates accuracy and reproducibility of the method. Recovery study indicates that these drugs could be quantified simultaneously without interference of excipient present in formulation. The developed UV spectroscopic method is suitable for the analysis of DMP and PTZ in combined dosage form. The accuracy was found between 99-100% for DMP and 98-99% for PTZ respectively. The precision (%RSD) was found to be 0.308 for DMP and 0.123 for PTZ respectively. The LOD was found to be 0.045 μg/ml for DMP and 0.01μg/ml for PTZ respectively. The LOQ was found to be 0.122 μg/ml for DMP and 0.059 μg/ml for PTZ respectively.

Keywords: Domperidone, Pantoprazole sodium, Simultaneous Equation, Method Validation, UV Spectrophotometer.