A robustustic Eco-friendly analytical method to quantify topotecan in pharmaceuticals by rp-hplc

Topotecan is an anti-cancer drug used against ovarian cancer. It acts by inhibiting DNA-topoisomerase-I. A simple, robust, accurate and precise assay RP-HPLC method having rapid stability indication has been developed and subsequently validated for the quantitative estimation of Topotecan in API and in solid dosage form. The method so proposed is based on quantification of drug Topotecan in reversed phase using water's C18 column which was maintained at an ambient temperature. The selected mobile phase consist of mixture of Acetonitrile: DMF: Water (60:10:30,v/v) at pH maintained to 2.5 with O-Phosphoric acid (1: 100,v/v). The flow rate used was 1.0ml/min and injection volume was 20ml, detected at the wavelength of 297nm. The method was validated according to ICH guideline. The method was found to be accurate, robust, reproducible and linear. The drug was exposed to variable stressed conditions and was studied using the proposed method. The results reflects That there were no interfering peaks from exicipients, impurities or degradative products generated during stress conditions. Thus the proposed method for quantifying the Topotecan is specific and can be applied in the quality control and stability study of sample as API and solid dosage form.