A rapid and sensitive UPLC–MS/MS method for quantification of erdosteine as bulk drug and in capsules as dosage forms

Abstract

A rapid, sensitive, specific ultra-performance liquid chromatography-tandem mass spectrometric (UPLC-MS-MS) method was developed for the determination of erdosteine (ERD) in pharmaceutical preparations. The chromatographic separation was achieved with 0.1% formic acid in combination with acetonitrile (25:75 v/v) using C18 UPLC column, 95Å, 2.1 x 50 mm, 1.8 µm. The flow rate was 0.15 mL/min and the total run time was 2.0 min. The column temperature was kept constant at 40 °C and the injection volume was 5 μL. Ibuprofen was used as internal standard (IS). The mass transitions of ERD and IS were m/z 249.9 → 231.8 and 205.1 → 161.0. Also, another product ion of ERD (m/z 249.80 → 231.80) was monitored as predictive ion during the analysis. The standard calibration curve shows determination coefficient (R2) greater than 0.996 with a range of 1-5000 ng/mL using the linear regression model. Within-run precision and between-run repeatability were expressed as relative standard deviation and were lower than 5%. The developed method was successfully applied in the analysis of ERD-containing capsule formulation indicating that the method could be used for routine quality control analyses. Keywords: erdosteine, UPLC-MS/MS, multiple reaction monitoring, pharmaceutical analysis, method validation