DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF IBUPROFEN AND FAMOTIDINE IN RAW MATIRIAL AND TABLET DOSAGE FORM
Balaji V.*, Nethaji A. and Dr. D. Nagavalli
ABSTRACT
A simple, rapid, selective and sensitive (RP-HPLC) method was developed and validated for the simultaneous estimation of Ibuprofen and Famotidine in raw material and tablet dosage form. The chromatographic separation was performed on a C8 grace column (150 mm×4.6 mm,5 mc)with a mobile phase comprising of mixture of 0.05mM potassium dihydrogen phosphate buffer and acetonitrile(85:15) pH 6.5 adjusted with 45% Potassium hydroxide, at a flow rate of 1 ml /min with detection at 265nm. As per international conference on harmonization(ICH) guidelines the method was validated for linearity, accuracy, presicion, limit of quantitation and limit of detection. Linearity of Ibuprofen was found to be in the range of 300 – 900 mcgml-1 and Famotidine was found to be in the range of 10- 30 mcgml-1. The correlation coefficients were 0.9998 for Ibuprofen and 0.9991 for Famotidine. The accuracy of the developed method was found to be 98.75 – 100.17 for Ibuprofen and 99.34 – 99.80 for Famotidine. The experiment shows the developed method is free from interference of excipients. It can be convenient adopted for the routine quality control analysis of the tablet dosage form.
Keywords: IBuprofen (IB), FAmotidine (FA) RP-HPLC.
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