Abstract

DEVELOPMENT AND VALIDATION OF REVERSE PHASE HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DICYCLOMINE HYDROCHLORIDE, MEFENAMIC ACID AND PARACETAMOL IN TABLET DOSAGE FORM

S.R. Lokhande, S.M. Mhetre, S.S. Pekamwar*, T.M. Kalyankar

School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded-431606. India.

ABSTRACT

A simple, rapid and reliable RP-HPLC method has been developed for qualitative and quantitative estimation of Dicyclomine Hydrochloride (DCL), Mefenamic Acid (MEFE) and Paracetamol (PARA) in bulk drug and pharmaceutical formulations using a mobile phase consisting mixture of methanol and 1% acetic acid (80:20 v/v) at pH 4.3 and at flow rate of 1.2 ml/min at 400 C temperature. An ODS C-18 (Hypersil 5μ, 250mm x 4.6 mm, i.d.) column was used as stationary phase. The retention time of Dicyclomine Hydrochloride, Mefenamic Acid and Paracetamol were 7.1 min., 4.4 min and 2.1 min. respectively. Linearity was observed at concentration range of 2000-4500 μg/ml for Dicyclomine Hydrochloride, 25-150 μg/ml for Mefenamic Acid and 50-300 μg/ml for paracetamol. Percent recoveries obtained for Dicyclomine Hydrochloride, Mefenamic Acid and Paracetamol were 99.63, 99.71and 99.78 respectively. The proposed method is precise, accurate, selective and rapid for the simultaneous determination of Dicyclomine Hydrochloride, Mefenamic Acid and Paracetamol.

Keywords: Dicyclomine Hydrochloride (DCL), Mefenamic Acid (MEFE), Paracetamol (PARA), Simultaneous estimation, Validation.