Stability indicating Method Development and Validation of Inavolisib and its impurities by RP-HPLC Method

Abstract

Aim: The present study describes about the development and validation of novel RP-HPLC analytical method for the analysis of Inavolisib and its impurities and to carry out stability studies by forced degradation to estimate the stability of drug and its impurities. The proposed method was novel for the estimation of anti cancer drug. Materials and Methods: Based on the solubility studies carried out at 25oC using variety of solvents and buffers, Acetonitrile and Ammonium formate pH-2.5/formic acid (40:60) were found to be suitable mixture of solvents for mobile phase system. The analysis of drug is accomplished by using Waters X-Terra RP-18 column (150mm x 4.6mm ID, 3.5µm) at 259 nm. Results and Discussions: The method is then validated according to the ICH guidelines. The analytical results revealed that the method developed is within the limits for all the validated parameters. The forced degradation studies revealed that 3.25% and 3.46% of Inavolisib degradation was observed in presence of peroxide and alkali conditions. Summary and Conclusion: From the results of the study, the sample recoveries were found within the limits. Hence the proposed method can be conveniently and easily adopted to the determination of Inavolisib and its impurities.