NOVEL UV- SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF VELPATASVIR IN API FORM

Spandana N., Spandana T. M., Aaron Mathew Reji, Suresha D. N.*

ABSTRACT

A novel, simple, accurate, and precise Zero order derivative spectroscopy method was developed and validated for the determination of Velpatasvir in API form. The stock solution was prepared by weighing 100 mg of standard Velpatasvir in 100 ml volumetric flask with 0.1M HCL. The stock solution was made to produce 1000 μg/ml with 0.1M HCL. Further dilutions were prepared as per procedure. The drug solution showed the maximum absorbance at 294 nm. The linearity was found in the concentration range of 2-12μg/ml. The correlation coefficient was found to be 0.999. The regression equation was found to be Y=0.0395x + 0.0001. The method was validated for linearity, accuracy, precision, robustness, ruggedness, LOD and LOQ. The LOD and LOQ for determination of Velpatasvir were found to be 0.058056μg/ml and 0.580563μg/ml respectively. Recovery of Velpatasvir was found to be in the range of 99.46-100.5%. Proposed method was successfully applied for the quantitative determination of Velpatasvir in API form.

Keywords: Velpatasvir, Zero order UV-Spectroscopy, 0.1M HCL, Accuracy.