Analytical Method Development and Validation for Metoclopramide Hydrochloride by Using RP-HPLC

Meghnath chaudhary*, Dr. C. Sreedhar, T. Sreenivasarao, Katikala Dharmendra
Department of Pharmaceutical analysis, Karnataka College of Pharmacy, 33/2, Thirumenahalli, Hegde Nagar Main Road, Jakkur Post, Bengaluru, Karnataka 560064

Abstract
A simple, rapid, and sensitive high-performance liquid chromatographic method was developed and validated for determination of Metoclopramide Hydrochloride. Separation of Metoclopramide Hydrochloride was achieved within a single chromatographic run on an XBridge ^TM column 5µm 4.6x250mm with UV detection at 274nm, under isocratic conditions, using Acetonitrile and Ammonium acetate buffer (P^{H _} 3.7) in 55:45 ratio. Validation parameters were performed to demonstrate linearity, accuracy, precision, LOD & LOQ in accordance to ICH guidelines.The current method demonstrates good linearity over the range of 5-30µg mL^-1. The correlation coefficient (r²) is 0.9918.Relative standard deviation for precision and accuracy was less than 2.. Limit of detection (LOD) was found to be 0.1601 µg ml^-1 and limit of quantification (LOQ) was found to be 0.5337µg ml^-1.
Keywords: Metoclopramide Hydrochloride, reverse phase, high performance liquid chromatography, validation