RP-HPLC ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF IBUPROFEN AND FAMOTIDINE IN BULK AS WELL IN PHARMACEUTICAL DOSAGES FORM BY USING PDA DETECTOR

Abstract

This study was designed to develop and validate a simple, sensitive, precise, and specific reverse phase high-performance liquid chromatographic (RP-HPLC) method for the determination of Ibuprofen and Famotidine in bulk and its tablet dosage forms. The RP-HPLC separation was carried out by reverse phase chromatography on XTerra column C18 (4.6 X 150 mm, 3.5 mm Make: ACE) or equivalent with a mobile phase composed Sodium Dihydrogen Ortho Phosphate and the pH has been adjusted to 2.5 by Orthophosporic Acid and Acetonitrile in the ratio of 30:70 v/v in isocratic mode at a flow rate of 1.2 ml/min. The run time was maintained for 8 minutes. The detection was monitored at 236 nm. The Accuracy was calculated and the % Recovery was found 98.4 %-

101.8 % for the drug Ibuprofen and 98.4 %-100.5 % for the drug Famotidine respectively and reproducibility was found to be satisfactory. The calibration curve for Ibuprofen was linear from 100 to 200 ppm for the drug Ibuprofen and 3.32- 6.65 ppm for the drug Famotidine respectively. The inter-day and intra- day precision was found to be within limits. The proposed method has adequate sensitivity, reproducibility, and specificity for the determination of Prasugrel in bulk and its tablet dosage forms. The limit of detection and limit of quantification for Ibuprofen were found to be 0.18 µg/ml and 0.63 $\mu $g/ml respectively. The limit of detection and limit of quantification for Famotidine were found to be 0.046 $\mu $g/ml and 0.15 µg/ml respectively. The present work was undertaken with the aim to develop and validate a rapid and consistent RP- HPLC in which the peaks will be appear with a short period of time as per ICH guideline. The proposed method is simple, fast, accurate, and precise for the quantification of Ibuprofen & Famotidine in the dosage form, bulk drugs as well as for routine analysis in quality control.