Development and Validation of a Novel Stability Indicating RP-UPLC Method for Simultaneous Estimation of Methylparaben, Mometasone Furoate and Eberconazole Nitrate in Combined Topical Pharmaceutical Dosage Form

Abstract

A novel, rapid, simple, stability indicating RP-UPLC method development and validation for simultaneous estimation of methylparaben (MP), mometasone furoate (MF) and eberconazole nitrate (EN) in topical pharmaceutical dosage form. Isocratic chromatographic separation was achieved on Acquity BEH C18, column using mobile phase consist of buffer (0.1%v/v triethylamine in water pH 6.0 by Glacial acetic acid), acetonitrile in the ratio (40:60, v/v) at flow rate 0.4 mL/min and detection was monitored at 235 nm by using photo-diode array detector. The method shows excellent linearity over the range of 2.75-152.7 µg/mL, 4.45-60.7 µg/mL and 9.10-606.6 µg/mL for methylparaben, mometasone furoate and eberconazole nitrate respectively. Recovery was found for all the components to be in the range of 98.4-101.7%. Stability indicating capability of developed method was established by analysing forced degradation samples in which spectral purity of methylparaben, mometasone furoate and eberconazole nitrate along with separation of degradation products from analytes peak. The proposed method was successfully applied for the quantitative estimation of MP, MF and EN in cream sample.