ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF EFONIDIPINE HYDROCHLORIDE ETHANOLATE AND METOPROLOL SUCCINATE 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 Metoprolol Succinate and Efonidipine hydrochloride ethanolate.The chromatographic strategy utilized Acquity UPLC BEH C-18 column of dimensions (50x2.1mm, 1.7μm), using isocratic elution with a mobile phase of acetonitrile and 0.1% Tri ethyl amineof pH-2.5/OPA (80:20). A flow rate of 0.5 ml/min, injection volume of 5μl and a detectorwavelength of 265 nm utilizing the PDA detector were given in the instrumental settings. LODand LOQ for the active ingredient were established with respect to test concentration. Thecalibration chart plotted was linear with a regression coefficient of R2 > 0.999, means thelinearity was within the limit. Specificity, linearity, accuracy, robustness, ruggedness weredetermined as a part of method validation and the results were found to be within the acceptablerange. Validation of the proposed method was carried out according to an internationalconference on harmonization (ICH) guidelines. The proposed method to be fast, simple, feasibleand affordable in assay condition. During stability tests, it can be used for routine analysis ofproduction samples and to verify the quality of drug samples during stability studies.