Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ACECLOFENC AND LANSOPRAZOLE

Nandakumar R.*, Chandrashekhar Javali and Poornesh Gowda A. S.

ABSTRACT

A simple, sensitive, precise rapid and accurate reverse phase high performance liquid chromatography (RP- HPLC) method was developed and validated for simultaneous estimation of Aceclofenac and Lansoprazole. The Chromatographic separation was achieved by using Cosmosil C18(250 mm×4.6 mm, 5μ) as stationary phase and mobile phase consists of Acetonitrile: Ammonium acetate buffer with pH 5.0 (55:45 v/v) with a flow rate of 1ml/min. The analysis was performed at ambient temperature and the eluent was monitored at 280nm using UV detector. The retention time of Aceclofenac and Lansoprazole was found to be 3.3min and 4.2 min respectively and the calibration curves were linear (r2 = 0.9995 and 0.9995) over a concentration range of 100-500μg/ml for Aceclofenac and Lansoprazole respectively. The Limit of detection (LOD) for Aceclofenac and Lansoprazole was observed to be 0.006μg/ml and 0.002μg/ml respectively, the limit of quantitation (LOQ) was found to be 0.2μg/ml and 0.4μg/ml respectively. The developed method was validated as per ICH guidelines using parameters like linearity, specificity, system suitability, precision, ruggedness, robustness, accuracy. All the validation parameters were found to be well within the acceptance criteria. Hence the proposed method can be used for the routine analysis of Aceclofenac and Lansoprazole in bulk and tablet dosage forms.

Keywords: Aceclofenac, Lansoprazole, RP-HPLC, Simultaneous estimation. ICH guidelines.