DEVELOPMENT AND VALIDATION OF AN HPLC-MS/MS METHOD FOR SIMULTANEOUS DETERMINATION OF IVERMECTIN, FEBANTEL, PRAZIQUANTEL, PYRANTEL PAMOATE AND RELATED COMPOUNDS IN FIXED DOSE COMBINATION FOR VETERINARY USE

摘要

High performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) method for simultaneous quantification of ivermectin, febantel, praziquantel and pyrantel pamoate in addition to the qualitative determination of febantel-related compound C and praziquantel-related compounds A, B and C in tablets was developed and validated. Chromatographic separations were achieved using isocratic elutio n (200 μL/min) on a C8 column (50 x 2.1 mm i.d) coupled with a C8 (10 x 2.1 mm i.d) guard column maintained at 20 .C. The mobile phase consisted in water/acetonitrile (15:85 v/v) containing 0.1% formic acid and 3 mmol/L ammonium formate. The injection volume used was 20 μL. The validation parameters indicated that the method has high sensitivity and selectivit y with excellent linearity (r .0.99). The observed range of recovery was 93.26% to 101.36% with a RSD of <5% for intraday and interday precision. Sample analyses demonstrated a lack of standardization in the amounts of these drugs, which may contribute to their toxicity or a reduction in efficacy, depending of the sample used. The proposed HPLC-MS/MS method is presented as an alternative option for the quality control of pharmaceutical preparations containing these drugs