Bioavailability Studies on Developed Prochlorperazine Maleate Sustained Release Tablets by HPLC

Dhandapani Nagasamy Venkatesh,

Abstract

A sensitive and reproducible high performance liquid chromatography (HPLC) method has been developed and validated for the quantification of prochlorperazine sus- tained release tablets in human plasma, after solid phase extraction (SPE). Best chromatographic resolution was achieved on a reverse-phase Phenomenex C 18 column us- ing the mobile phase consisted of a mixture of 20 mM disodium hydrogen ortho phosphate–acetonitrile (95:5) in an isocratic elution with a total run time of 12 min. Linear plot was obtained in the concentration range of 15–300 ng/ml ( r 2 = 0.99). Lower limit of quantification (LLOQ) was found to be 15 ng/ml. Average recovery of the analyte was found to range from 98.25 to 99.13% in plasma at the concentrations of 45, 150 and 270 ng/ml. The intra and inter-day relative standard deviations of low quality con- trol (LQC), medium quality control (MQC) and high qual- ity control (HQC) of prochlorperazine were found to be 2.63, 3.25, 2.83 and 3.57, 5.88 and 3.78 respectively. The present method was successfully applied in the pharma- cokinetic study of prochlorperazine in human plasma.

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