Abstract

An analytical method for simultaneous determination of erythromycin propionate and its active metabolite, erythromycin base, in human plasma by high-performance liquid chromatography–electrospray mass spectrometry (HPLC–ESI-MS) was developed and validated. Roxithromycin was selected as the internal standard. The samples were directly injected after simple deproteinized procedure only. The separation was achieved on a Johnson Spherigel analytical column packed with 5 μm C 18 silica, employing acetonitrile −0.1% formic acid aqueous solution (50:50) as mobile phase. The quantification of target compounds was obtained by using a selected ion monitoring (SIM) at m/ z 790.7 for erythromycin propionate, m/ z 734.7 for erythromycin base and m/ z 837.8 for roxithromycin. The correlation coefficients of the calibration curves were better than 0.997 ( n = 6), in the ranges from 2 ng/ml to 1 μg/ml, and from 1 to 10 μg/ml for erythromycin propionate and base. The method can provide the necessary sensitivity, precision and accuracy to allow the simultaneous determination of both compounds in a patient's plasma following a single administration of erythromycin stinoprate capsule (500 mg erythromycin base equivalent).

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