ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BUPROPION HCl AND DEXTROMETHORPHAN HBr BY USING RP-UPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM

ABSTRACTThe current investigation was pointed at developing and progressively validating novel, simple,responsive and stable RP-UPLC method for the simultaneous measurement of activepharmaceutical ingredients of Dextromethorphan HBr and Bupropion HCl. A simple, selective,validated and well-defined stability that shows isocratic RP-UPLC methodology for thesimultaneous determination of Dextromethorphan HBr and Bupropion HCl. Thechromatographic strategy utilized Phenomenex C18 column of dimensions (50x1.7 mm, 2.1μm),using isocratic elution with a mobile phase of acetonitrile and 0.1% Perchloric acid (30:70). Aflow rate of 0.5 ml/min, injection volume of 5μl and a detector wavelength of 240 nm utilizingthe PDA detector were given in the instrumental settings. LOD and LOQ for the activeingredient were established with respect to test concentration. The calibration chart plotted waslinear with a regression coefficient of R2 > 0.999, means the linearity was within the limit.Specificity, linearity, accuracy, robustness, ruggedness were determined as a part of methodvalidation and the results were found to be within the acceptable range. Validation of theproposed method was carried out according to an international conference on harmonization(ICH) guidelines. The proposed method to be fast, simple, feasible and affordable in assaycondition. During stability tests, it can be used for routine analysis of production samples and toverify the quality of drug samples during stability studies.