New Analytical Method Development and Validation of Tenofovir disoproxil fumarate in Bulk and Tablet by Using UV- Spectrophotometric Method

Author : Swathi K, Jose Gnana Babu C, Tamizh Mani T

A novel, simple, accurate and precise Zero order derivative 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 258 nm in 0.1 N H2SO4. The Linearity was found to be in the concentration range of 5-40μg/ml and the correlation coefficient was found to be 0.9995 and it has showed good linearity, reproducibility, precision in this concentration range. The regression equation was found to be Y = 0.0243 X + 0.0134. The % recovery values were found to be within 99.82 -100.14 % showed that the method was accurate. The LOD and LOQ were found to be 0.3266 and 0.9800 mcg / ml, respectively. The % RSD values were less than 2. The method has been validated according to ICH guidelines 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.

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