Abstract

NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TENOFOVIR DISOPROXIL FUMARATE IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY USING UV- SPECTROPHOTOMETRIC METHOD

Sowmya HG*, Swathi K, Chandana RS3, Ranjitha MT, Mithun MS, Nandeesh HD

ABSTRACT

A novel, simple, accurate and precise Area Under curve spectroscopic method was developed and validated for the estimation of Tenofovir Disoproxil Fumarate in bulk and Pharmaceutical dosage forms and has an absorption maximum at 255-265 nm in 0.1 N NaoH. The Linearity was found to be in the concentration range of 5-35μg/ml and the correlation coefficient was found to be 0.9996 and it has showed good linearity, reproducibility, precision in this concentration range. The regression equation was found to be Y = 0.0282X + 0.0107. The % recovery values were found to be within 99.78 -100.03 % showed that the method was accurate. The LOD and LOQ were found to be 0.4060 and 1.1218 mcg / ml, respectively. The % RSD values were less than 2. The method has been validated according to ICH guidelines[20-22] for linearity, accuracy, precision, robustness, ruggedness. Limit of detection and limit of quantitation. Proposed method was successfully applied for the quantitative estimation of Tenofovir Disoproxil Fumarate in bulk and pharmaceutical dosage form.

Keywords: Tenofovir disoproxil fumarate, Area Under curve Spectroscopy, 0.1N NaoH, Accuracy.