Abstract

METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION STUDIES OF IRINOTECAN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Koduru Swathi*, Tahmeena Farooqui, Sidra Tul Muntaha, Syeda Amtul Ayesha, Syeda Shama and Sarah Imam Siddiqui

ABSTRACT

A reverse phase isocratic HPLC was developed and validated for the determination of Irinotecon in bulk and Pharmaceutical dosage forms. Method development was carried out on Symmetry ODS RP C18,5m, 15mm x 4.6mm i.d., maintained at ambient temperature), Waters Prominence Liquid Chromatography. The mobile phase was a mixture of Acetonitrile: Phosphate buffer pH adjusted to 3.80 orthophosphoric acid in the ratio of 80:20 v/v and the flow rate was set at 1.0 ml/min and UV detection at 226 nm. Validation parameters were evaluated for the method according to the ICH (Q2R1) guidelines. In the linearity study, linearity was observed from 0-70μg/ml with correlation coefficient of 0.999. The limit of detection and limit of quantization for the method were 0.08μg/ml and 0.24μg/ml, respectively. The statistical analysis shows that the method was found to be accurate, reliable, simple and reproducible. The intra- and inter-assay precisions were satisfactory; the values of relative standard deviations did not exceed 2%. The accuracy of the method was proved; the mean recovery of Irinotecon was found to be 98-102%. The chromatographic retention time of proposed method was 2.793 min. The proposed method was successfully applied for the quantitative determination of Irinotecon in bulk form and Pharmaceutical dosage forms could be used for routine analysis with phenomenal accuracy and precisions.

Keywords: Irinotecon, RP-HPLC, Method Development, Method Validation, ICH Guidelines, Accuracy, Precision.