Stability Indicating RP-HPLC Method for the Estimation of Selumetinib in Capsule Dosage Form

The principal objective of this study is to develop and validate a new, simple, accurate, fast, economical, precise, and reproducible Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) for the estimation of selumetinib in a capsule dosage form. The chromatographic separation was performed on the Inert Sustain C18 (250 mm × 4.6 mm i.d., 5 μm particle size) column and a mobile phase comprising of 0.1 % Trifluoroacetic acid in Water and Acetonitrile in the ratio of (60:40 % v/v) was used. The diluent consisting of water and acetonitrile in the ratio of (50:50 % v/v) was used. The flow rate was kept at 1.1 ml/min and detection was carried out at 258 nm. The retention time of selumetinib was found to be about 5.9 min. The parameters such as accuracy, precision, linearity, ruggedness, robustness and LOD, LOQ were used for validating the developed method according to ICH guidelines. The method was linear over a concentration range of 50-175 μg/ml with a regression coefficient of 0.9998. Limit of Detection and Limit of Quantitation values for selumetinib was found to be 0.15 μg/ml and 0.47 μg/ml, respectively. The percentage RSD of every parameter was found within the limit. The stress testing studies were executed to give degradation products by exposing the drugs to hydrolytic, photolytic, oxidative, acid, alkali, and thermal degradation conditions. The acquired data showed that the degradation product successfully separated without any intrusion, which establishes the stability-indicating nature of a developed method. The accurate, simple, precise, economical, reliable, and easy for RP-HPLC method has been successfully developed and validated. The developed method was applied for routine quality control analysis of selumetinib in capsule dosage forms.