High-performance liquid chromatographic analysis of mometasone furoate andits degradation products - Application to in vitro degradation studies

A method of analysis of mometasone furoate in pharmaceutical formulations a nd biological fluids is necessary to study the degradation kinetics and det ermine its stability. A simple high-performance liquid chromatographic meth od was developed for simultaneous determination of mometasone furoate and i ts degradation products in human plasma. Plasma (0.5 ml) was extracted with dichloromethane after addition of the internal standard, dexamethasone 21- acetate. Separation was achieved on a Beckman Cs column with UV detection a t 248 nm. The calibration curve was linear ranging from 0.2 to 100 mug/ml. The mean extraction efficiency was > 86%. Precision of the assay was < 10% (CV). and was within 10% at the limit of quantitation (0.2 mug/ml). Bias of the assay was lower than 7%. The limit of detection was 50 ng/ml for a 0.5 -ml sample. The assay was applied successfully to the in vitro kinetic stud y of degradation of mometasone furoate in human plasma and simulated biolog ical fluids. (C) 2001 Elsevier Science B.V. All rights reserved.