Selective and rapid liquid chromatography-mass spectrometry method for the determination of lercanidipine in human plasma.

A specific liquid chromatography-mass spectrometric (LC-MS/MS) assay was developed and validated for the determination of lercanidipine, a dihydropyridine calcium channel blocker, in human plasma. Lercanidipine R-D3 was used as internal standard (IS). The drug was extracted from plasma using liquid-liquid extraction technique utilizing hexane: ethyl acetate as extraction solvent. The samples were analyzed using a prepacked Thermo Hypersil C(8) column and a mobile phase composed of a mixture of aqueous acetic acid and triethylamine in methanol. An ion trap mass spectrometer equipped with electrospray ionization (ESI) source operating in the positive ion mode was used to develop and validate the method. The method was proved to be sensitive and specific by testing six different human plasma batches. Linearity was established for the concentration ranges of 0.1-16 ng/ml with a regression factor of 0.9996. The lower limit of quantitation was identifiable and reproducible at 0.1 ng/ml with a precision of 7.2%.