Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DIETHYLCARBAMAZINE CITRATE, GUAIPHENESIN AND CETIRIZINE HYDROCHLORIDE BY RP-HPLC METHOD

Mazharhusen Mirza* and Dhara Rathod

Abstract

The present work involves the development and validation of RPHPLC methods for the estimation of Diethylcarbamazine Citrate, Guaiphenesin, Cetirizine Hydrochloride. A simple, accurate, precise and robust RP-HPLC method has been developed and validated for estimation of Diethylcarbamazine Citrate, Guaiphenesin, Cetirizine Hydrochloride. Using Syncronis C18 column (250 mm × 4.6 mm id, 5 μm particle size) as column, using mobile phase Methanol : Phosphate buffer (pH 3), 0.5% TEA (adjusting pH 3 with 10% OPA) (80:20, v/v) at 0.8 ml/min flow rate and detection was carried out at 230 nm. Retention time for DECC, GUA and CTZ was found to be 3.408, 4.077 and 6.395 respectively. Linearity of the developed method was 0.9988, 0.9990 and 0.9989 in the range of 120-270 μg/ml, 60-135 μg/ml and 4-9 μg/ml for DECC, GUA and CTZ respectively. The developed methods were validated successfully as per ICH guidelines are accurate, precise and simple.

Keywords: Diethylcarbamazine Citrate, Guaiphenesin, Cetirizine Hydrochloride, RPHPLC, Validation.