LC-MS/MS Method Development and Validation for the Determination of Nifedipine in Human Plasma

The main purpose of this study was to develop a simple, precise, rapid, green and accurate method for the simultaneous quantification of nifedipine in human plasma; The resolution of peaks was best achieved with Intersil ODS gum C18 (4.6 × 50 mm, 3.5 μm) column. Samples were chromatographed in a gradient mode (acetonitrile – water – formic acid). The mobile phase was delivered at a flow rate of 0.500 mL/min into the mass spectrometer ESI chamber; The total chromatographic run time was 4 minutes. Nifedipine eluted at ~3.24 min. A linear response function was established at 1 - 130 ng/mL in human plasma. The % mean recovery in LQC, MQC and HQC was 104.1 %, 105.0 % and 108.7 %. The lowest concentration with the RSD <20% was taken as LLOQ and was found to be 1.01 ng/mL. The % accuracy of LLOQ samples prepared with the different biological matrix lots was found 100.5 % for nifedipine, which was found within the range of 80.00-120.00 % for the seven different plasma lots. A rapid method was developed for the determination of nifedipine in human plasma. The method was strictly validated according to the ICH guidelines. Acquired results demonstrate that proposed strategy can be effortlessly and advantageously applied for routine examination of nifedipine in human plasma.