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

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


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

https://doi.org/10.31142/ijtsrd22812



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

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.

Metformin, RP-HPLC, ICH Guidelines


IJTSRD22812
Volume-3 | Issue-3, April 2019
415-419
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)

International Journal of Trend in Scientific Research and Development - IJTSRD having online ISSN 2456-6470. IJTSRD is a leading Open Access, Peer-Reviewed International Journal which provides rapid publication of your research articles and aims to promote the theory and practice along with knowledge sharing between researchers, developers, engineers, students, and practitioners working in and around the world in many areas like Sciences, Technology, Innovation, Engineering, Agriculture, Management and many more and it is recommended by all Universities, review articles and short communications in all subjects. IJTSRD running an International Journal who are proving quality publication of peer reviewed and refereed international journals from diverse fields that emphasizes new research, development and their applications. IJTSRD provides an online access to exchange your research work, technical notes & surveying results among professionals throughout the world in e-journals. IJTSRD is a fastest growing and dynamic professional organization. The aim of this organization is to provide access not only to world class research resources, but through its professionals aim to bring in a significant transformation in the real of open access journals and online publishing.

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