1Pharmaceutical Quality Assurance Department, B.K. Mody Government Pharmacy College, Rajkot, Gujarat, India
2Amneal Pharmaceutical Pvt. Ltd., 1 New England Avenue, Piscataway, NJ, 07936, USA
Principle motive behind this work is to develop accurate, precise, simple, specific and rapid stress degradation kinetic method of Tadalafil using UV spectrophotometer.
Estimation was carried out at 284 nm using UV spectrophotometer and methanol as a diluent. Stress degradation kinetic study was performed in different conditions like acid hydrolysis, base hydrolysis, oxidative, thermal and UV degradation. This method was validated for its linearity, accuracy, precision, LOD and LOQ, specificity and repeatability as per the ICH guideline recommendations.
Calibration curve for Tadalafil was found linear over a concentration range of 4 to 40 μg/ml. Force degradation kinetic study was performed from 0 to 24 hrs at room temperature, with the percentage degradation shows within the acceptable limits of 10 to 40 % of degradation, and this method was validated as per ICH guideline Q2 (R1). The aforementioned method additionally was successfully used for the analysis of bulk as well as tablet dosage form without any interference.
The present work provides complete study of Tadalafil which is based on kinetic stress degradation by UV Spectrophotometry. The degradation kinetic study was shown satisfactory results in different stress condition. The proposed method was cost beneficial and specified for estimation of marketed formulation without any interference.
Tadalafil, Stress degradation, Kinetic study, UV- Spectrophotometry, Validation, ICH guideline Q2 (R1)
