Development of Validated Stability Indicating RP-HPLC-PDA Method for Camptothecin Analysis.

ABSTRACT

A novel stability-indicating Reverse Phase High Pressure Liquid Chromatography (RP-HPLC-PDA) method was developed and validated for quantitative determination of Camptothecin (CPT) in bulk, formulation and in dissolution samples using Inertsil-C18 (250mm x 4.6mm, 5μm) column with mobile phase combination of 15mM Ammonium acetate and acetonitrile (6040) at a flow rate of 1mL/min. Eluents were monitored at a wavelength of 254 nm with an injection volume of 20µL. CPT was completely degraded in oxidative and base hydrolysis conditions and around 37% in acidic conditions and no degradation of CPT was observed with thermal, thermal/humidity and photo conditions. CPT showed linearity over a concentration range of 2-10μg/mL with a regression coefficient (R2) of 0.994 and correlation coefficient (R) of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) values for CPT were 0.025μg/mL and 0.077μg/mL respectively. The developed method was validated as per ICH guidelines. The method was also successfully applied to dissolution testing of controlled release formulation.