Development and Validation of Stability Indicating RP-HPLC Method for Midodrine Hydrochloride in Bulk and Solid Dosage Form

Gauri Rathod , Diksha Ghorpade , Shivani Kotamkar , Samiksha Burange

Midodrine hydrochloride, Sstability indicating RP-HPLC, Inherent stability, Photo stability, Validation

The present work involves the development of a stability indicating RP-HPLC assay method for estimation of this drug in bulk and tablets and also to establish the inherent stability of midodrine hydrochloride through stress studies. The present study was undertaken with the primary objective to establish the inherent stability of midodrine hydrochloride through stress studies under a variety of ICH- recommended tests conditions using validated RP-HPLC method. The present work, forced degradation study of midodrine hydrochloride was carried out according to the ICH- guideline Q1A (R2). The drug was subjected to acid (0.1 N HCl), alkaline (0.1 N NaOH) and neutral hydrolysis conditions as well as an oxidative decomposition at 80oC. Photo stability and thermal study was also carried out. The RP- HPLC separate all degradation products formed under various stress condition using a mobile phase, 0.02% triethaylamine: methanol: acetonitrile (20:20:60) pH 4.53 adjusted with acetic acid at a flow rate 1.0 ml/min, on an isocratic HPLC system containing UV-visible detector and hypersil C18 column, detection was carried out at 291 nm. Maximum degradation products were formed under the neutral and oxidative condition while significant degradation was observed in acidic, photolytic, oxidative and thermal conditions respectively.

Published Paper   E-Certificate

"Development and Validation of Stability Indicating RP-HPLC Method for Midodrine Hydrochloride in Bulk and Solid Dosage Form", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.5, Issue 7, page no.125 - 135, July-2020, Available :https://ijsdr.org/papers/IJSDR2007014.pdf

Volume 5 Issue 7, July-2020

Pages : 125 - 135

Paper Reg. ID: IJSDR_192067

Published Paper Id: IJSDR2007014

Downloads: 000347233

Research Area: Pharmacy

Country: Amravati, Maharashtra, India

Published Paper PDF: https://ijsdr.org/papers/IJSDR2007014

Published Paper URL: https://ijsdr.org/viewpaperforall?paper=IJSDR2007014

ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJSDR(IJ Publication) Janvi Wave

This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition