A NEW RP-HPLC STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF IBUPROFEN & FAMOTIDINE IN BULK AS WELL IN PHARMACEUTICAL DOSAGES FORM BY USING PDA DETECTORAbstract
The RP-HPLC separation was carried out by reverse phase chromatography on XTerra column C18 (4.6 × 150mm, 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 & 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 mins. The detection was monitored at 236nm. The Accuracy was calculated, and the % Recovery was found 98.4%- 101.8% for the drug Ibuprofen & 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 200ppm for the drug Ibuprofen & 3.32-6.65 ppm for the drug Famotidine, respectively. The inter-day and intra-day precision were found to be within limits. The proposed method has adequate sensitivity, reproducibility, and specificity for the determination of Ibuprofen & Famotidine 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 µg/ml, respectively. The limit of detection and limit of quantification for Famotidine were found to be 0.046µg/ml and 0.15µg /ml, respectively. The method was applied for the determination of Ibuprofen and Famotidine in the presence of their degradation products formed under a variety of stress conditions. The bulk active pharmaceutical ingredient was subjected to thermal, hydrolytic (acidic and basic) and oxidative stress conditions and stressed samples were analyzed by the proposed method. 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.
S. A. Kumar *, M. Debnath, J. V. L. N. S. Rao and D. G. Sankar
Department of Pharmaceutical Analysis & Quality Assurance, A. K. R. G. College of Pharmacy, Nallajerla, Andhra Pradesh, India.
08 March 2014
20 May 2014
26 June 2014
01 September 2014