Abstract

STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR ITRACONAZOLE AND TERBINAFINE HYDROCHLORIDE IN COMBINED PHARMACEUTICAL DOSAGE FORM

Shweta K. Thutan* and Zarna R. Dedania

ABSTRACT

A sensitive, specific, accurate and stability indicating HPLC Method was Developed and Validated for Itraconazole And Terbinafine Hydrochloride using a YMC, C18 column (150 x 4.6mm, 5μm) column and a mobile phase composed of Acetonitrile: Buffer 0.1 TEA% (adjusted pH: 10), 80:20, v/v. The retention times of Itraconazole and Terbinafine Hydrochloride was found to be 4.29 min and 15.38 min respectively. The linearity was established for Itraconazole and Terbinafine Hydrochloride the range of 12-32 μg/ml and 30-80μg/mlwith correlation coefficient 0.9983 and 0.999 respectively. The LOD and LOQ for Itraconazole were found to be 0.52μg/ml and 1.5816μg/ml respectively and for Terbinafine Hydrochloride 1.57μg/ml and 4.79μg/ml respectively. The percentage recoveries of Itraconazole and Terbinafine Hydrochloride were found to be in the range of 98.93 to 101.83 % and 98.28 to 101.52 % respectively. The Itraconazole and Terbinafine Hydrochloride were subjected to acidic, alkaline, oxidation, thermal and photo degradation condition. Percentage degradation for Itraconazole and Terbinafine Hydrochloride in acidic and alkali condition was found to be 1.0 and 0.9% and 7.9 and 10.1% respectively. In Oxidative stress condition for Itraconazole and Terbinafine Hydrochloride were found to be 21.2 and 2.3% respectively. Thermal and Photolytic stress degradation for Itraconazole and Terbinafine Hydrochloride was found to be 18.0 and 0.2% and 29.1 and 5.0% respectively. Itraconazole and Terbinafine Hydrochloride to be more susceptible to thermal, while less susceptible to oxidative condition.

Keywords: Itraconazole and Terbinafine Hydrochloride, Stability Indicating HPLC, Validation.