Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMERATE IN BULK AND TABLET DOSAGE FORM BY RP-HPLC

Modugula Jyothsna* and Podili Venkata Seshagiri

Abstract

An accurate, precise and simple stability indicating Chromatographic method for development and validation for the simultaneous estimation of Emtricitabine and tenofovir Disoproxil Fumerate in its pharmaceutical dosage form by HPLC was carried out by using ACE C18 (150 mmx4.6 mm i.d, 5 μ) column with gradient program, mobile phase A: 0.01M Citrate buffer pH 4.0 with Ammonia & mobile phase B: ACN , Flow rate 1.2 ml/min., Injection volume 20 μl, UV detection was performed by using wavelength at 270 nm. The method was linear over the concentration range of 20 μg/mL to 70 μg/mL for Emtricitabine (r2- 0.9997) and 25 μg/mL to 100 μg/mL for Tenofovir disoproxil fumerate (r2- 0.9996) with limits of detection and quantification of 0.112 μg/ml & 0.346 μg/ml for Emtricitabine and 0.192 μg/ml & 0.585 μg/ml for tenofovir Disoproxil Fumerate. Forced degradation study was carried out according to ICH guidelines in Acid Degradation, Base Degradation, Oxidative Degradation, Thermal Degradation conditions and the method was specific. A study to establish the stability of standard and test preparations on bench top was conducted and the solutions were stable for 24 hours.

Keywords: Emtricitabine, Tenofovir Disoproxil Fumerate, RP-HPLC, ICH Guidelines.