STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION &VALIDATION OF LOPERAMIDE HYDROCHLORIDE & SIMETHICONE IN PHARMACEUTICAL DOSAGE FORM

Abstract

A simple, sensitive, specific, accurate RP-HPLC method was developed for the simultaneous estimation of Loperamide HCl and Simethicone in pharmaceutical dosage form. RP-HPLC separation was achieved on a Zodiac C18 (150 mm x 4.6 mm, 5μm) column and isocratic elution. The mobile phase composed of phosphate buffer: acetonitrile (pH 2.3) (70:30 v/v) [HPLC Grade] at flow rate 1ml/min with UV detection at 230 nm. Run time is 7min. The retention times of Loperamide HCl and Simethicone were found to be 2.776 min and 3.60 min respectively. Linearity was established for Loperamide HCl and Simethicone in the range of 0.201-3.018μg/ml and 12.420-186.300μg/ml respectively. System precision and method precision was found to be within the limits of the acceptance criteria. Relative standard deviation of Loperamide HCl and Simethicone for System precision was found to be 1.111 and 0.277 respectively and method precision was found to be 0.3 and 0.33 respectively. The percentage recoveries for Loperamide HCl and Simethicone were found to be in the range of 99.93-101.5% and 100.16-101.06% respectively. The forced degradation studies of Loperamide HCl and Simethicone were found to be within the acceptance criteria. This method can be successfully employed for simultaneous quantitative analysis of Loperamide HCl and Simethicone in bulk drugs and formulations. The results indicate that there is no interference from excipients for the proposed method, thus making the method simpler, less time consuming and suitable for routine estimation of Loperamide HCl and Simethicone tablet formulation.