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Asian Journal of Pharmaceutical Analysis
Year : 2020, Volume : 10, Issue : 4
First page : ( 177) Last page : ( 181)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2020.00032.0

A stress degradation kinetic study of tadalafil bulk and tablet dosage form by UV spectrophotometry

Dr. Vyas Amitkumar J.1, Gol Dhruvanshi A.1,*, Dr. Patel Ajay I.1, Dr. Patel Ashok B.1, Dr. Patel Nilesh K.1, Chudasama Alpesh2

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

*Corresponding Author E-mail: dhruvanshigol4064@gmail.com

Online published on 27 April, 2021.

Abstract

Aim

Principle motive behind this work is to develop accurate, precise, simple, specific and rapid stress degradation kinetic method of Tadalafil using UV spectrophotometer.

Method

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.

Results

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.

Conclusion

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.

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Keywords

Tadalafil, Stress degradation, Kinetic study, UV- Spectrophotometry, Validation, ICH guideline Q2 (R1).

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