Development and Validation of RP-HPLC method for Simultaneous Estimation of Esomeprazole and Domperidone in Capsule Formulation
PRAFULLA M SABALE, Dhiraj Bhagwat, VIDYA P SABALE, DEBARSHI KAR MAHAPATRA
Esomeprazole, Domperidone, Simultaneous estimation, Capsule, Formulation, Validation.
Background: The literature has indicated that there is no “analytically significant” method ever developed by the chemists across the globe for the simultaneous determination of esomeprazole (ESO) and domperidone (DOM) in a capsule formulation. Hence, there is a need for the development of novel, simple, sensitive, rapid, accurate and reproducible analytical methods for the routine estimation of ESO and DOM in capsule dosage form. Material and Methods: The present novel developed analytical method utilizing the phosphate buffer (pH 8.5): acetonitrile (50:50) on a Lichrospher ® 100 C18 column by using a flow rate of 1 mL/min where an excellent resolution with sharp peaks of ESO and DOM present in capsule formulation. Results: The retention peaks were observed at 4.386 min and 7.688 min, respectively. The analytical method was validated in accordance with the ICH guidelines Q2A and Q2B where desired linearity, accuracy, precision, and robustness were observed. The system suitability parameters represented a very high reproducibility and better separation efficacy. In a modified stability study, the oxidative degradation was studied comprehensively where a mechanistic abstraction of the proton by the OH radical was predicted. Conclusion: The method can be conventionally used for quality control and routine analysis of drugs in pharmaceutical dosage forms in pharmaceutical industries and laboratories.