A new, rapid, economical and isocratic reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the estimation of related substances in altretamine bulk drug. Altretamine is an antineoplastic agent used in palliative treatment of persistent or recurrent ovarian cancer. The chromatographic method was optimized using the samples generated from forced degradation studies and the impurity spiked solution. Good resolution between the process related impurities and degradation products from the analyte was achieved on Zorbax SB-C18 column using the mobile phase consists a mixture of 10 mM ammonium carbonate in water pH adjusted to 8.0 with ammonium hydroxide solution and Methanol in the ratio of 35:65 v/v at detection of 227 nm wavelength. The limit of detection and the limit of quantitation for altretamine and its process related impurities were established. The stressed test solutions were assayed against the qualified standard of Altretamine and the mass balance in each case was in between 98.7%-99.8% indicating that the developed liquid chromatography method was stability-indicating. Validation of the developed LC method was carried out as per International Council for Harmonization requirements. The developed method was found to be suitable to check the quality of bulk samples of altretamine during its storage and stability studies.
Loading....