Stability Indicating RP-HPLC Method Development and Validation for Dexamethasone

Pankaj N. Kulkarni, C.K. Jadhav, A.S. Nipate, Alaknanda M. Dodake-Supekar and C.H. Gill*

Department of Chemistry, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad-431004, India

*Corresponding author: Tel : +91 70 28247050, E-mail: chgill16@gmail.com; pankajnkulkarni@gmail.com

Abstract

A new, simple, reliable and reproducible stability indicating RP-HPLC assay method has been developed for quantitative analysis of dexamethasone from dexamethasone tablets. This developed method has been validated according to ICH guideline with respect to system suitability, specificity, precision, linearity, accuracy and robustness. An isocratic condition of mobile phase water (0.1% orthophosphoric acid):acetonitrile in a ratio of 60:40, v/v at a flow rate of 1.0 mL/minute over RP 2.5 Fortis C18, 100 × 4.6 mm, 2.5 μm, column was at 27 ºC maintained. This method is specific and showed excellent linear response with correlation coefficient (R2) values of 0.999. In forced degradation, the proposed method has been investigated with different stress conditions as hydrolytic, oxidative, thermal and humid as recommended by ICH guidelines. An accurate and reliable reversed-phase HPLC method for the analysis of dexamethasone in dexamethasone tablets was developed and validated successfully.

Keywords

Dexamethasone, RP-HPLC, Forced degradation.

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