Simultaneous Densitometric and UPLC Methods for the Determination of Paracetamol and Metoclopramide HCL

Abstract

Two simple, accurate and precise methods were presented for the simultaneous quantitative estimation of paracetamol and metoclopramide hydrochloride. The first is based on TLC separation of the two drugs, followed by densitometric measurement at 274 nm using a developing system composed of dichloromethane - methanol - conc. ammonia (8:2:0.05 by volume). The second method is based on UPLC separation of the cited drugs at 230 nm using C18 column and a mobile phase of 0.1% ortho-phosphoric acid (PH 3.5) – acetonitrile (70: 30, v/v). Regression analysis of Beer’s plots showed good correlations (r = 0.9996 - 0.9998) over concentration ranges of 1.5 – 15 and 0.1-0.6 μg/spot or 5-25 and 0.25 – 1.5 μg mL-l for paracetamol and metoclopramide  HCL using the two suggested methods, respectively. The proposed methods were also successfully applied to analyze both drugs in their pharmaceutical formulation; Migracid® tablets with mean recoveries ranging from 99.03 to 101.1%. The results obtained were validated as per ICH guidelines and statistically analyzed and found to be in accordance with those given by a reported method.