European Journal of Biomedical and Pharmaceutical Sciences

RP-HPLC ESTIMATION OF CLOFAZIMINE IN SOFT GELATINE CAPSULE: DEVELOPMENT, VALIDATION AND STABILITY INDICATIONS

Amareshwar Shabada, Humera Badar*, Syeda Saba Sultana and Nikhat Fatima

ABSTRACT

Stability indicating reverse phase high performance liquid chromatography method was developed for the estimation of Clofazimine in bulk drug and soft gelatin capsules. The chromatographic separation was achieved on ODS C18 column using mobile phase comprising 10 mM citrate buffer: acetonitrile, in which pH of buffer is adjusted with 1N HCL solution in ratio of (70:30 v/v), flow rate was 1.0 ml/min and eluents were detected by UV detector at 283 nm. Retention time of Clofazimine was found to be 5.205 min. Linearity range was found over the concentration range 25-75 μg/ml. Clofazimine was subjected to various stress conditions i.e. Acid, Base, Oxidative, Thermal and Photolytic degradation. The degradation peak of formulation of Clofazimine were well resolved from the pure peak. The proposed method were validated according to the ICH guidelines and it can be suitable for quality control analysis of Clofazimine in soft gelatin capsule.

Keywords: Clofazimine, Reverse Phase High Performance Liquid Chromatography Method, soft gelatin capsule, degradation, Validation.