Next Article in Journal
Ant Plant (Myrmecodia tuberosa) Hypocotyl Extract Modulates TCD4+ and TCD8+ Cell Profile of Doxorubicin-Induced Immune-Suppressed Sprague Dawley Rats In Vivo
Previous Article in Journal
Scientia Pharmaceutica, Autorenhinweise 2012
Article Menu

Article Versions

Export Article

Open AccessArticle
Sci. Pharm. 2013, 81(4), 1043-1056; doi:10.3797/scipharm.1306-06

Design of Experiment (DOE) Utilization to Develop a Simple and Robust Reversed-Phase HPLC Technique for Related Substances’ Estimation of Omeprazole Formulations

Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
*
Author to whom correspondence should be addressed.
Received: 11 June 2013 / Accepted: 12 August 2013 / Published: 12 August 2013
Download PDF [361 KB, uploaded 29 September 2016]

Abstract

A simple, fast, and sensitive reversed-phase HPLC method with UV detection was developed for the quantitation of omeprazole and its eleven related compounds (impurities) in pharmaceutical formulation using the Thermo Accucore C–18 (50 mm x 4.6 mm, 2.6 μm) column. The separation among all the compounds was achieved with a flow rate of 0.8 mL min−1 employing a gradient program of mobile phase A [0.08 M glycine buffer pH 9.0: acetonitrile; 95:05 (v/v)] and mobile phase B [acetonitrile: methanol; 65:35 (v/v)]. The chromatographic detection was carried out at a wavelength of 305 nm. The method was validated for specificity, linearity, and recovery. The huskiness of the method was determined prior to validation using the Design of Experiments (DOE). The ANOVA analysis of DOE with a 95% confidence interval (CI) confirmed the buffer pH of mobile phase A (p <0.0001) and column temperature (p<0.0001) as significant Critical Method Parameters (CMPs).
Keywords: DOE; HPLC/UPLC; Compatible; Related Substances; Anova; Method development; Chromatography DOE; HPLC/UPLC; Compatible; Related Substances; Anova; Method development; Chromatography
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

MANRANJAN, V.C.; YADAV, D.S.; JOGIA, H.A.; CHAUHAN, P.L. Design of Experiment (DOE) Utilization to Develop a Simple and Robust Reversed-Phase HPLC Technique for Related Substances’ Estimation of Omeprazole Formulations. Sci. Pharm. 2013, 81, 1043-1056.

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