DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR QUANTITATION OF CLOFARABINE

Author:

Shirman Asif, ,Khan Gulam J.,Ansari Yaasir A.,Qazi Shoeb,Inamdar Z.E.,Siddiqi Hifjurrahman,Syed Umar F.,Syed Tasqeeruddin,Syeda Shaheen

Abstract

This experiment aims to develop and validate the RP-HPLC method for clofarabine in a bulk and pharmaceutical dosage form. Chromatographic separation was achieved on Inertsil ODS 3V (150× 4.6 mn) diameter column. The mobile phase comprised of phosphate buffer (pH 4.0): methanol (40:60) at a flow rate of 1 mL min-1 and all eluents were detected at 270 nm. The runtime was 10 minutes. Calibration curves at five levels for clofarabine were linear in the range of 10-30 µg mL-1. Accuracy for clofarabine was studied in the range of 50-150 % quality control standard levels. A validated method was found to be accurate, reproducible, linear, precise, and robust.

Publisher

Indian Drug Manufacturers' Association (IDMA)

Subject

Drug Discovery,Pharmaceutical Science,Pharmacology

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