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Abstract

BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR APLIDINE IN RAT PLASMA AND THEIR PHARMACOKINETIC STUDIES BY LCMS

Asha Eluru* and Dr. K. Surendra Babu

ABSTRACT

A simple, sensitive and rapid chromatographic method was developed and validated for quantification of Aplidine in rat plasma using Dexamethasone as internal standard. Chiral cell ODH (2.1x150mm, 5μ) column provided chromatographic separation of analyte followed by detection with mass spectrometry. The method involved simple isocratic chromatographic condition and mass spectrometric detection in the positive ionization mode using a QTRAP- 5500 system. The total run time was 10 min. The proposed method has been validated with the linear range of 5-75 ng/ml of Aplidine. The intraday precision and interday precision %RSD values were within the limit. The overall recovery of Aplidine was 98.1% - 99.2% respectively.

Keywords: Aplidine, Bio-analytical method, LCMS.


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