DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF MECLIZINE HYDROCHLORIDE AND CAFFEINE IN BULK AND TABLET DOSAGE FORM

Shinde Ganesh Shashikant*

ABSTRACT

A simple and more economic RP-HPLC method was developed and subsequently validated for the simultaneous determination of Meclizine hydrochloride and Caffeine in bulk and pharmaceutical dosage form. The chromatographic conditions were standardized using a Grace C18, (250×4.6mm,5μ). The analyte detection was carried out by using a UV detector set at a wavelength of 228 nm. The mobile phase consisted of Methanol: Water (80:20) at pH 3 adjusted with ortho phosphoric acid (OPA) with the flow rate of 1.0 ml/min and retention time of Meclizine hydrochloride and Caffeine was found to be 4.128 min and 5.107 min respectively. The calibration curves of two drugs were linear with correlation coefficients of 0.9991 and 0.9992 over a concentration range of 5- 25μg/ml for Meclizine hydrochloride and 4-20μg/ml for Caffeine. This method has been validated and shown to be accurate, precise, specific, sensitive, linear, robust and fast. Meclizine hydrochloride and Caffeine were subjected to different degradation stress conditions. The degradation products were well resolved from that of pure standard drugs (Meclizine hydrochloride and Caffeine) with significant different retention time values. The current method has been statistically validated according to the ICH guidelines and this method has been subsequently developed and applied successfully to determine the levels of Meclizine hydrochloride and Caffeine in a combined formulation and in the routine quality control analysis with good accuracy and sensitivity.

Keywords: Meclizine hydrochloride, Caffeine, RP-HPLC.