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Bioavailability Studies on Developed Prochlorperazine Maleate Sustained Release Tablets by HPLC

Abstract

Dhandapani Nagasamy Venkatesh, Sundaram Sankar, Subramania Nainar Meyyanathan, Selvadurai Muralidharan, Ramaswamy Shanmugam, Kannan Elango, Bhojraj Suresh and Kumaraswamy Santhi

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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