Analytical Method Development and Validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines

Dr. Avish Maru; Dr. Anil Jadhav | Dr. Prashant Malpure; Mr. Nilesh Nikam

Title:
Analytical Method Development and Validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines

Authors:
Mr. Nilesh Nikam | Dr. Avish Maru | Dr. Anil Jadhav | Dr. Prashant Malpure
DOI:
https://doi.org/10.31142/ijtsrd22812

Cite This Article :

Mr. Nilesh Nikam | Dr. Avish Maru | Dr. Anil Jadhav | Dr. Prashant Malpure "Analytical Method Development and Validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-3, April 2019, pp.415-419, URL: https://www.ijtsrd.com/papers/ijtsrd22812.pdf

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Abstract :
A simple and reproducible method was developed for Metformin (MET) by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). Metformin was separated on C18 column [4.6x250mm, particle size 5µm], using combination of phosphate buffer with pH of 3.0 and Methanol at the UV detection of 238nm. Isocratic elution of phosphate buffer with pH of 3.0 and Methanol was used as a mobile phase with various ratios and flow rates, eventually 30:70 v/v phosphate buffer with pH of 3.0 and Methanol was being set with the flow rate of 1mL/min. The statistical validation parameters such as linearity, accuracy, precision, inter-day and intra-day variation were checked, assay studies of Metformin were within 98% to 102% indicating that the proposed method can be adoptable for quality control analysis of Metformin.

Keywords :
Metformin, RP-HPLC, ICH Guidelines

Publication Details:

Unique Identification Number : IJTSRD22812

Published In : Volume-3 | Issue-3, April 2019

Page Number(s) : 415-419

Publisher Name : IJTSRD | www.ijtsrd.com | E-ISSN 2456-6470

Copyright © 2019 by author(s) and International Journal of Trend in Scientific Research and Development Journal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0)

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