Development and validation of RP-HPLC method for estimation of camptothecin in mixed micelle formulation

Abstract

Camptothecin is a potent anticancer agent. Numerous studies on camptothecin had been reported in the literature; here an effort is made to develop a new HPLC method for camptothecin estimation in pharmaceutical dosage forms that will be accurate, simple, and sensitive. A fast, simple, and accurate spectrophotometric technique for the quantitative measurement of Camptothecin in active pharmaceutical components and pharmaceutical dosage formulations has been developed and validated. An RP-HPLC method was devised using Acetonitrile: Water (90:10) as the mobile phase, 1mL/min flow rate, and the temperature of 30 ℃. The linearity was observed in the concentration range of 20-100 μg/ml with maximum wavelength of 219 nm and a correlation value (R2) of 0.9995. The current method was used to determine the concentration of camptothecin in mixed micelles containing camptothecin, PF108, and TPGS. The suggested method's accuracy, precision, sensitivity, and ruggedness were evaluated using validation parameters. Recovery of camptothecin was found to be in the range of 98–102%, indicating that the developed method is accurate. The accuracy and robustness were found to be within acceptable limits and in compliance with ICH standards. This method can be used for routine analysis of camptothecin of pharmaceutical formulation in any pharmaceutical dosage form.