Full Factorial Design for Optimization, Development, Validation of RPHPLC Method and Stability-Indicating Method for Tamsulosin and Dutastaride
Dalvi Sampada D.1,*, Nanda Rabindra K.2, Chitlange Sohan S2
1Marathwada Mitramandal's College of Pharmacy, Kalewadi, Pune, Maharashtra, India, 411033.
2Dr. D. Y. Patil Institute of Pharmaceutical Science and Research, Pimpri, Pune, Maharashtra, India, 411018.
*Corresponding Author E-mail: email@example.com
Online published on 17 October, 2017.
High performance liquid chromatographic method was optimized developed and validated as per the ICH guidelines. Full factorial design was used to optimize the effect of variable factors. Full factorial design was used during forced degradation experiments and the factors/combination of factors which were most likely to affect degradation under various conditions was identified and was optimized further. In this study the methanol: water in the 80: 20 ratios were used as mobile phase for the analysis. Drugs were exposed to acid, alkali and oxidation effect by hydrogen peroxide, dry heat, wet heat and photolytic conditions. The retention time values of tamsulosin and dutastaride were found to be 1.9min and 7.94 min respectively. Percent recovery in terms of accuracy was found in the range of 96.7–102.9%. Drugs were found to be stable under wet heat, dry heat and photolytic conditions, but substantial degradation was observed under acid, alkali and oxidative conditions. The method was found to be simple and fast by making use of experimental design.
HPLC, Dutastaride, Tamsulosin, Stability indicating method Full factorial Design.