Next Article in Journal
Crinum Latifolium Leave Extracts Suppress Immune Activation Cascades in Peripheral Blood Mononuclear Cells and Proliferation of Prostate Tumor Cells
Previous Article in Journal
DNA-Binding Interaction Studies of Microwave Assisted Synthesized Sulfonamide Substituted 8-Hydroxyquinoline Derivatives
Article Menu

Article Versions

Export Article

Open AccessArticle
Sci. Pharm. 2011, 79(2), 309-322; doi:10.3797/scipharm.1101-06

A Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine Hydrochloride in Liquid Oral Dosage Form

1
Analytical Research and Development, IPDO, Dr. Reddy’s Laboratories Ltd. Bachupally, Hyderabad500072, A.P, India
2
Department of chemistry, J. N. T. University, Kukatpally, Hyderabad-85, A.P, India
*
Author to whom correspondence should be addressed.
Received: 6 January 2011 / Accepted: 10 February 2011 / Published: 12 February 2011
Download PDF [362 KB, uploaded 28 September 2016]

Abstract

A selective, specific and stability-indicating gradient reverse phase highperformance liquid chromatographic (HPLC) method was developed for the determination of Ranitidine in presence of its impurities, forced degradation products and placebo substances such as saccharide and parabens. Ultraviolet detection was performed at 230 nm. Separate portions of the drug product and ingredients were exposed to stress conditions to induce oxidative, acidic, basic, hydrolytic, thermal and photolytic degradation. Ranitidine was found to degrade significantly at acidic, basic and oxidative stress conditions but was stable at heat and humidity. The developed method was validated as per International Conference on Harmonization (ICH) guidelines. The method was validated over this range for (i) system suitability (ii) specificity, (iii) precision, (iv) limit of detection and limit of quantification, (v) linearity, (vi) accuracy, (vii) robustness. The method was found to be precise, accurate, linear and robust. The proposed method was successfully employed for estimation of Ranitidine impurities in pharmaceutical preparations.
Keywords: Method development; Stability-indicating; Ranitidine; Stress conditions; Impurities; Oral Solution; RP-HPLC Method development; Stability-indicating; Ranitidine; Stress conditions; Impurities; Oral Solution; RP-HPLC
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

Scifeed alert for new publications

Never miss any articles matching your research from any publisher
  • Get alerts for new papers matching your research
  • Find out the new papers from selected authors
  • Updated daily for 49'000+ journals and 6000+ publishers
  • Define your Scifeed now

SciFeed Share & Cite This Article

MDPI and ACS Style

SHARMA, N.; Singh RAO, S.; REDDY, P.S.; MALLESWARA REDDY, A. A Validated Stability-Indicating Liquid-Chromatographic Method for Ranitidine Hydrochloride in Liquid Oral Dosage Form. Sci. Pharm. 2011, 79, 309-322.

Show more citation formats Show less citations formats

Article Metrics

Article Access Statistics

1

Comments

[Return to top]
Sci. Pharm. EISSN 2218-0532 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top