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

Year : 2025 | Volume : 12 | Issue : 02 | Page : 07 15
    By

    Mayur Sudhakar Patil,

  • Kamalesh Mistry,

  • Dhananjay Mistry,

  • Shivam Rongpi,

  • Pratyush Kumar Brahma,

  • Mitul Bhoi,

  1. Research Scholar, Department of Pharmacy, Faculty of Phar maceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  2. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  3. Lecturer, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  4. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  5. Assistant Professor, School of Pharmacy, Rai University, SH 144, Saroda, Dholka, Ahmedabad, Gujarat, India
  6. Assistant Professor, School of Pharmacy, Rai University, SH 144, Saroda, Dholka, Ahmedabad, Gujarat, India

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: RP-HPLC, metoclopramide hydrochloride, method validation, tablet dosage form, mobile phase, ICH guidelines, retention time

[This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production ]

How to cite this article:
Mayur Sudhakar Patil, Kamalesh Mistry, Dhananjay Mistry, Shivam Rongpi, Pratyush Kumar Brahma, Mitul Bhoi. RP-HPLC Analytical Method Development and Validation for Quantitative Estimation of Metoclopramide Hydrochloride in Solid Oral Formulations. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2025; 12(02):07-15.
How to cite this URL:
Mayur Sudhakar Patil, Kamalesh Mistry, Dhananjay Mistry, Shivam Rongpi, Pratyush Kumar Brahma, Mitul Bhoi. RP-HPLC Analytical Method Development and Validation for Quantitative Estimation of Metoclopramide Hydrochloride in Solid Oral Formulations. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2025; 12(02):07-15. Available from: https://journals.stmjournals.com/rrjodfdp/article=2025/view=229558


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Regular Issue Subscription Review Article
Volume 12
Issue 02
Received 03/04/2025
Accepted 16/04/2025
Published 22/07/2025
Publication Time 110 Days
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