ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING STUDIES OF AVANAFIL BY USING RP-HPLC TECHNIQUE

Abstract

Objective: The project was aimed at developing an analytical method to quantify Avanafil drug either alone or in tablet formulation, including stability studies by practicing RP-HPLC technique.

Methods: The RP-HPLC technique was carried to work out an analytical method and inspecting consistency of the method by performing the different validation parameters. The degradation studies were performed under different physical and chemical conditions following the ICH guidelines. The column used was Inertsil ODS Column C₁₈ (4.6×250mm)5µm.

Findings: In the course of stream lining the analytical method, we have clinched on to use the mobile phase with the combination of Methanol: 0.1% OPA (75:25v/v). The drug was detected at 246 nm in UV. The retention time was at 3.14 min and the linearity range of was from 0.5 µg/ml to 10µg/ml with the Regression coefficient calculated to be (R²) 0.9978. The corresponding recognition limits (LOD and LOQ) was 0.02µg/ml and 0.08µg/ml respectively. Precision studies were carried out and the RSD values were found to be less than two. The degradation studies were successfully conducted.

Novelty: The significant advantages were reduction of retention time almost one minute less, the lower limit in linearity being at least 10 times less and the mobile phase used was quite cheaper than the reported methods. The other part was that, the usability of the method to quantify even though the drug was degraded nearly to 10 % in presence of the unknown degradants. The method is also sensitive, reproducible, quick and economical.