Table of Contents
ISRN Chromatography
Volume 2013 (2013), Article ID 506923, 12 pages
http://dx.doi.org/10.1155/2013/506923
Research Article

Development and Validation of a Stability Indicating RP-HPLC Method for the Determination of Two Sun Protection Factors (Koptrizon and Tinosorb S) in Topical Pharmaceutical Formulations Using Experimental Designs

1Analytical Research and Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad, Andhra Pradesh 500090, India
2Department of Chemistry, National Institute of Technology, Durgapur, West Bengal 713209, India

Received 11 March 2013; Accepted 15 April 2013

Academic Editors: C. Akbay and J. A. P. Coelho

Copyright © 2013 Chinmoy Roy and Jitamanyu Chakrabarty. 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.

Abstract

A novel, simple, validated stability indicating HPLC method was developed for determination of Koptrizon and Tinosorb S. Stability indicating power of the method was established by forced degradation study. The chromatographic separation was achieved with Waters X Bridge column, by using mobile phase consisting of a mixture of acetonitrile : tetrahydrofuran : water (38 : 38 : 24, v/v/v). The method fulfilled validation criteria and was shown to be sensitive, with limits of detection (LOD) and quantitation (LOQ) of 0.024 and 0.08 μg  for Koptrizon and 0.048 and 0.16 μg  for Tinosorb S, respectively. The developed method is validated for parameters like precision, accuracy, linearity, solution stability, specificity, and ruggedness as per ICH norms. Design expert with ANOVA software with linear model was applied and a 23 full factorial design was employed to estimate the model coefficients and also to check the robustness of the method. Results of the two-level full factorial design, 23 with 10 runs including two-centre-point analysis based on the variance analysis (ANOVA), demonstrated that all three factors, as well as the interactions between retention time of Koptrizon, Tinosorb S, and USP plate count for Koptrizon, are statistically significant.