RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF IFOSFAMIDE IN PURE FORM AND PHARMACEUTICAL DOSAGE FORM

A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Ifosfamide in pure form and pharmaceutical dosage form. Separation of Ifosfamide was successfully achieved on a Symmetry ODS C18 (4.6 x 150mm, 5mm) column in an isocratic mode utilizing ACN: Methanol in the ratio of 60:40% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 251nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 10-50mcg/mL for Ifosfamide. The correlation coefficient was found to be 0.999 for Ifosfamide. The LOD and LOQ for Ifosfamide were found to be 1.3µg/mL and 4.0µg/mL respectively. The proposed method was found to be good percentage recovery for Ifosfamide, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.

Keywords: Ifosfamide, RP-HPLC, Accuracy, ICH Guidelines.