Abstract

METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE IN BULK AND COMBINED TABLETS DOSAGE FORMS

Ameesh Shukla*, Dr. Vandana Jain and Dr. Snehalatha Boddu

Abstract

A simple, selective, sensitive and precise, simultaneous highperformance liquid chromatographic analysis of tablets containingParacetamol, Phenylephrine Hydrochloride and TriprolidineHydrochloride was described. Good chromatographic separation wasachieved using a Prontosil C18 column (250 x 4.6mm, 5μm) andmobile phase consisting of acetonitrile: 0.1M potassium dihydrogenphosphate buffer (52:48) with 2.5ml of Triethyl Amine, adjusted to pH3.2 with Orthophosphoric acid, at flow rate 1ml/min. The detector wasset at 215nm. The retention time of Paracetamol, PhenylephrineHydrochloride and Triprolidine Hydrochloride was found to be 2.910min, 2.190 min and 3.377 min, respectively. The linear ranges for Paracetamol,Phenylephrine Hydrochloride and Triprolidine Hydrochloride were 260-910μg/ml, 8-28μg/mland 2-7μg/ml, respectively. The recoveries of Paracetamol, and PhenylephrineHydrochloride and Triprolidine Hydrochloride in pharmaceutical preparation were all greaterthan 98% and their relative standard deviations were not more than 2.0%. The proposedmethod can be effectively applied for the simultaneous estimation of three drugs in bulk andin combined dosage form.

Keywords: Paracetamol, Phenylephrine Hydrochloride, Triprolidine Hydrochloride, RPHPLC, Validation.