A sensitive, selective and rapid bioanalytical method using liquid chromatography–tandem mass spectrometry has been developed for the quantification of trifluoperazine in human plasma. Trifluoperazine‐D8 was used as the internal standard and the extraction from human plasma was performed by liquid–liquid extraction technique using tertiary butyl methyl ether as the solvent. Chromatographic separation was carried out on Zodiac C18 column (50 × 4.6 mm, 3 μm) employing a mixture of acetonitrile, methanol and 5 mm ammonium bicarbonate buffer in water (85:10:5, v/v/v) at a flow rate of 0.55 ml/min. The linearity was established within the concentration range of 5–1,250 pg/ml with r2 > 0.99. The results of all of the validation parameters as per the US Food and Drug Administration guidelines were within the acceptance limits. The pharmacokinetics of trifluoperazine after oral administration of a syrup of 1 mg dose under fasting conditions was determined by successful application of the present method.
A rapid, selective and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for quantification of procyclidine hydrochloride in human plasma using Procyclidine D11 hydrochloride as internal standard. Liquid-liquid extraction technique with methyl tertiary butyl ether was used for the extraction of plasma samples. Chromatographic separation of the analyte and the internal standard from the endogenous components was done on Zodiac C18 column (50 × 4.6 mm, 5 µm) using a mixture of methanol and 0.1% formic acid in water (70:30, v/v) as mobile phase at a flow rate of 1 mL/min with the run time of 2 min. The detection of the eluents was done using multiple reaction monitoring (MRM) in positive ion mode. Linearity of the method was established in the concentration range of 0.5 to 120 ng/mL. Full validation of the method was done as per USFDA guidelines and the results were well within the acceptance limits. The successful application of the method was done on healthy human subjects under fasting conditions, proving it to be used for bioequivalence and bioavailability (BA/BE) studies of procyclidine.
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