ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF PARACETAMOL AND DICLOFENAC SODIUM BY USING RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM

ABSTRACTThe current investigation was pointed at developing and progressively validating novel, simple,responsive and stable RP-HPLC method for the simultaneous measurement of activepharmaceutical ingredients of Diclofenac Sodium and Paracetamol. The chromatographicstrategy utilized Kromasil C-18 column of dimensions (150x4.6 mm, 3.5μm), using isocraticelution with a mobile phase of acetonitrile and Ammonium acetate of pH-2.5 adjusted with OPA(20:80). A flow rate of 1.0 ml/min, injection volume of 10μl and a detector wavelength of 278nm utilizing the PDA detector were given in the instrumental settings. LOD and LOQ for theactive ingredient were established with respect to test concentration. The calibration chart plottedwas linear 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.