RP-HPLC method for the determination of cabazitaxel in bulk and injection dosage form

Suresh Kumar Raju Vidyadharani

Abstract

An RP-HPLC method has been developed and validated for the quantification of cabazitaxel in injection dosage form. The desired chromatographic separation was achieved on the Inertsil ODS 3V (150 mm × 4.6 mm, 5 μm) HPLC column using isocratic elution at 254 nm detection wavelength. The optimized mobile phase consists of mixture of 0.1M NaH2PO4 and methanol in the ratio of 60:40 (v/v). The method showed linearity over the range of 24-72 μg/ml with regression coefficient value of 0.9999. The limits of detection and quantitation were found to be 0.052 μg/ml and 0.175 μg/ml, respectively. The recovery for all of the components was in the range of 100.394- 100.693% with percent relative standard deviation of less than 1%. The proposed method was successfully applied for the quantitative determination of cabazitaxel in injection dosage form.

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