Development and Validation of Cost Effective UV-Spectrophotometric Method for Estimation of Domperidone in Bulk and Pharmaceutical Formulations

摘要

Simple and cost effective UV-spectrophotometric method was developed for the estimation of domperidone in bulk and pharmaceutical formulations. Domperidone was analyzed at 284 nm in 100 mM hydrochloric acid (pH 1.2). Apparent molar absorptivity and Sandell's sensitivity were found to be 1.27 × 10~4 L mol~(-1) cm~(-1) and 0.034336 pg cm~(-2)/0.001A, respectively which infer good sensitivity of the method. The method demonstrated linearity in concentration range of 5-35 pg mL~(-1) (regression equation: absorbance = 0.0289 × concentration in pg mL~(-1) + 0.0077; R~2 = 1) in selected media. Method was fully validated for selectivity, accuracy, precision, robustness as per ICH guidelines. The detection and quantification limits were found to be 0.398 and 1.121 μg mL~(-1), respectively. The results of various validation parameters confirmed that the proposed method is accurate, selective and precise (relative standard deviation < 2 %), while being simple and cost effective. This method was found suitable for qualitative and quantitative estimation of domperidone in bulk and different formulation.