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Abstract

Liquid Chromatography Tandem Mass Spectrometry Method for Quantification of Solifenacin in Human Plasma and its Application to Bioequivalence Study

A hasty, specific and robust assay based on liquid-liquid extraction and liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI MS-MS) has been developed and validated for the quantitative analysis of Solifenacin ( a drug used for urinary incontinence ) in human plasma using Solifenacin D5 as internal standard (ISTD). The precursor to product ion transitions of m/z 363.20/110.10 and m/z 368.14/110.20 were used to measure the analyte and the ISTD, respectively. The method was validated in terms of selectivity, matrix effect, sensitivity, linearity, precision and accuracy, various stabilities (standard stock solution stability in refrigerator and at room temperature, stock dilution stability at refrigerator and room temperature, auto sampler stability, freeze thaw stability, long term stability- 65 o C ± 10o C & long term stability- 22 o C ± 5°C, reagent stability, bench top stability, dry extract stability, wet extract stability in refrigerator, effect of potentially interfering drugs, dilution integrity, recovery, lon suppression through infusion, and blood Stability. The mean percentage recovery of Solifenacin and the internal standard was 65.39 ± 3.646% and 66.24 ± 2.209% respectively. The assay exhibited a linear dynamic range of 0.200 to 30.361 ng mL-1. The RSD % of intra-day and inter-day assay was ≤15%. The application of this assay was demonstrated in a bioequivalence study and will be ideal for clinical pharmacokinetic studies in study population with as lower as 0.200 ng mL-1 analytical sensitivity and as little as 300 μL plasma sample.


Author(s): Nishant Paliwal, Peeyush Jain, Naveen Dubey, Sandeep Sharma, Siddharth Khurana, Rishabh Mishra and Sarvesh Kumar Paliwal

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