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Research & Reviews: A Journal of Drug Formulation, Development and Production Review Article

RP-HPLC Analytical Method Development and Validation for Quantitative Estimation of Metoclopramide Hydrochloride in Solid Oral Formulations

  1. Mayur Sudhakar Patil Department of Pharmacy, Faculty of Phar maceutical Science, Mewar University, Gangrar, Chittorgarh
  2. Kamalesh Mistry Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  3. Dhananjay Mistry Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  4. Shivam Rongpi Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  5. Pratyush Kumar Brahma School of Pharmacy, Rai University, SH 144, Saroda, Dholka, Ahmedabad
  6. Mitul Bhoi School of Pharmacy, Rai University, SH 144, Saroda, Dholka, Ahmedabad

Abstract

RP-HPLC technique formulated for the numerical assessment of Metoclopramide Hydrochloride in tablet formulation has been confirmed for reliability. A C18 column facilitated the chromatographic separation using a mobile phase comprising 60:40 (v/v) potassium dihydrogen phosphate buffer: meth anol mixture. Such method was used to detect, where the retained time was 6.78 minutes and Metoclo pramide Hydrochloride produced a clear peaked at 273 nm. Results were in agreement with ICH Q2 (R1) guidelines and validate the method for correctness, proportionality, consistency, distinctiveness, and reliability. The proportionality of the technique was excellent in the presence of a wide concentra tion range, as well as high recovery values and low relative standard deviation, confirming its repro ducibility. It was found that the LODs and the LOQs were within acceptable sensitivity ranges. It has been validated for routine quality control determination of Metoclopramide Hydrochloride in pharma ceutical preparations and can be further used in stability and Pharmacokinetic study.

Keywords

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