ANALYTICAL METHOD VALIDATION FOR THE DETERMINATION OF RELATED SUBSTANCE IN SOFOSBUVIR 400MG TABLET BY USING REVERSE PHASE HPLC TECHNIQUE
Irshad Alam*, Junaid Ali and Kashif Ahmed
ABSTRACT
The present work is a development and validation of a method for
quantitative measurement of degradation of active pharmaceutical
ingredient (API) Sofosbuvir i.e. SF10, SF11, SF12, SF13 in the drug
product by using the Reverse Phase High Performance Liquid
Chromatography (HPLC) analytical method with UV detection system
for the qualitative and quantitative determination. Chromatographic
separation was achieved by using gradient method on L1 column as a
Stationary Phase with the specification of 4.6mm × 10-cm, 3-μm, and
Phosphate buffer + Acetonitrile as a Mobile Phase, with different
composition at flow rate 1.0mL/minute, at 260nm UV detection, and at
20μL sample volume. The method found linear with an adequate level of precision and
accuracy over the concentration range of 0.5μg/mL to 995.98μg/mL. The percentage RSD for
precision and accuracy of the method was found to be less than 1%. The method was
validated according to the International Conference on Harmonization (ICH) guidelines with
respect to specificity, linearity, accuracy, precision, limit of detection (LOD), and limit of
quantitation (LOQ). The developed method successfully applied for analysis of related
substances of drug product “Sofosbuvir”.
Keywords: HPCL, gradient elution, simultaneous, Sofosbuvir
[Download Article]
[Download Certifiate]
