Stability-Indicating Validated Novel RP-HPLC Method for Simultaneous Estimation of Methylparaben, Ketoconazole, and Mometasone Furoate in Topical Pharmaceutical Dosage Formulation

Abstract

A simple, specific, precise, and accurate RP-HPLC method has been developed and validated for simultaneous estimation of Methylparaben (MP), Ketoconazole (KT), and Mometasone Furoate (MF) topical pharmaceutical dosage formulation. The separation was achieved by Waters X Terra C18 column using mobile phase consisting of buffer (triethyl amine in water, pH adjusted to 6.5 with glacial acetic acid)-acetonitrile (40 : 60, v/v) at a flow rate of 1.5 mL/min and detection at 250 nm. The method showed linearity with correlation coefficient <0.9999 over the range of 0.12–15.2 μ g/mL, 0.67–149.4 μ g/mL, and 0.42–7.6 μ g/mL for MP, KT, and MF, respectively. The mean recoveries were found to be in the range of 99.9–101.1% for all the components. The method was validated as per the ICH guidelines for linearity, limit of detection, limit of quantification, accuracy, precision, robustness and solution stability. Stability indicating capability of the developed method was established by analyzing forced degradation of samples in which spectral purity of MP, KT, and MF along with separation of degradation products from analytes peak was achieved. The method can be successfully applied for routine analysis of quantitative determination of MP, KT, and MF in pharmaceutical dosage form.