Abstract
A novel stability-indicating 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 (60:40) at a flow rate of 1mL/min. Eluents were monitored at a wavelength of 254 nm with an injection volume of 20�L. 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.
Highlights
Stability indicating methods have become an important aspect of analytical method validation and a part of US FDA requirements
CPT (Fig. 1) is (S)-4-ethyl-4hydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b] quinoline-3,14(4H,12H)-dione.But therapeutic application of unmodified CPT is hindered by very low solubility in aqueous media, high toxicity, and rapid inactivation through lactone ring hydrolysis
There is no stability indicating HPLC-PDA method published for the estimation of CPT in bulk, dosage form and in dissolution samples so far whereas stability indicating HPLC-PDA method was reported for 10-Hydroxy Camptothecin (Venkateshwarlu et al, 2012)
Summary
Stability indicating methods have become an important aspect of analytical method validation and a part of US FDA requirements. CPT being cytotoxic quinoline alkaloid inhibits DNA enzyme topoisomerase I showed remarkable anticancer activity against gastric carcinoma, hepatoma, leukemia and tumor of head and neck (Qing et al, 2006). There is no stability indicating HPLC-PDA method published for the estimation of CPT in bulk, dosage form and in dissolution samples so far whereas stability indicating HPLC-PDA method (gradient) was reported for 10-Hydroxy Camptothecin (Venkateshwarlu et al, 2012). Nalluri et al / Journal of Applied Pharmaceutical Science 6 (09); 2016: 140-146. In this investigation an attempt was made to develop a simple, accurate stability indicating RP-HPLC isocratic method for the analysis of CPT in bulk, formulation and dissolution samples.
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