Next Article in Journal
Protective Role of Curcumin Against N-Nitrosodiethylamine (NDEA) Induced Toxicity in Rats
Previous Article in Journal
Simultaneous Quantification of Baricitinib and Methotrexate in Rat Plasma by LC-MS/MS: Application to a Pharmacokinetic Study
Article Menu

Article Versions

Export Article

Open AccessArticle
Sci. Pharm. 2015, 83(2), 311-320; doi:10.3797/scipharm.1411-07

Development of a Forced Degradation Profile of Alosetron by Single Mode Reversed-Phase HPLC, LC-MS, and its Validation

Department of Pharmaceutical Analysis, JSS College of Pharmacy (A Constituent College of JSS University, Mysore), Udhagamandalam, The Nilgiris, Tamilnadu, 643001, India.
*
Author to whom correspondence should be addressed.
Received: 15 November 2014 / Accepted: 29 December 2014 / Published: 29 December 2014
Download PDF [344 KB, uploaded 7 September 2016]

Abstract

Determination of alosetron in the presence of its degradation products was studied and validated by a novel HPLC method. The separation of the drug and its degradation products was achieved with the Jones Chromatography C18 analytical column (150 mm x 4.6 mm; 3 μm) with a stationary phase in isocratic elution mode. The mobile phase used was 0.01 M ammonium acetate, pH-adjusted to 3.5 with glacial acetic acid and acetonitrile in the ratio of 75:25 (V/V) at a flow rate of 1 ml/min and UV detection was carried out at 217 nm. Further, the drug was subjected to stress studies for acidic, basic, neutral, oxidative, and thermal degradations as per ICH guidelines and the drug was found to be labile in base hydrolysis and oxidation, while stable in acid, neutral, thermal, and photolytic degradation conditions. An MS study has been performed on the major degradation products to predict the degradation pathway of alosetron. The method provided linear responses over the concentration range of 100–1500 ng/ml and regression analysis showed a correlation coefficient value (r2) of 0.994. The LOD and LOQ were found to be 1 ng/ml and 3 ng/ml, respectively. The developed LC method was validated as per ICH guidelines with respect to accuracy, selectivity, precision, linearity, and robustness.
Keywords: Alosetron; Degradation; ICH; Stress studies; Validation Alosetron; Degradation; ICH; Stress studies; Validation
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

KARTHIK, Y.; BABU, B.; MEYYANATHAN, S.N. Development of a Forced Degradation Profile of Alosetron by Single Mode Reversed-Phase HPLC, LC-MS, and its Validation. Sci. Pharm. 2015, 83, 311-320.

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