Validated Stability-Indicating Methods for Determination of Mometasone Furoate in Presence of its Alkaline Degradation Product

Abstract

Two novel stability-indicating TLC densitometric and chemometric methods were developed for the determination ofmometasone furoate (MF) in the presence of its alkaline degradation product (MF Deg). The developed TLC densitometricmethod (Method A) is based on the quantitative densitometric separation of MF from its alkaline degradation product on silica gel 60 F254 and measurement of the bands at 250 nm. The separation was carried out using hexane-chloroform-methanol-acetonitrile (6:6:1:0.3, by volume) as a developing system. A well-resolved and compact bands for (MF) and (MF Deg) at retention factors 0.36 and 0.66, respectively. Good resolution between (MF) and (MF Deg) assured the specificity of the proposed method. The method showed good linearity in the concentration range 0.5-5 μg/band with r2 = 0.9998. Themethod validation was performed according to ICH guidelines demonstrating to be accurate, precise, robust and sensitive. The LOD and LOQ were found to be 0.21 and 0.63 μg/band for MF, respectively. The developed TLC-densitometric method can be applied for identification and quantitative determination of MF in bulk drug and pharmaceutical dosage forms without any interference from excipients and degradates. Method B is a multivariate chemometric-assisted spectrophotometry, where classical least squares, principal component regression and partial least squares were applied. Statistical analysis of the results has been carried out revealing high accuracy and good precision.