Abstract

NEW 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 Area under curve spectroscopic method was developed and validated for the determination of Velpatasvir in API form and has an absorption maximum between 289-299 nm in 0.1M HCL. The Linearity was found to be in the concentration range of 2-12 μg/ml and the correlation coefficient was found to be 1 and it showed good linearity, reproducibility, and precision in this concentration range. The regression equation was found to be Y = 0.0357x + 0.0004. The % recovery values were found to be within 100.03 -100.5 % showed that the method was accurate. The LOD and LOQ were found to be 0.881259 and 8.81259 μg/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 determination of Velpatasvir in API form.

Keywords: Velpatasvir, Area under curve UV-Spectroscopy, 0.1M HCL, Accuracy.