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

Chinmoy Roy,Jitamanyu Chakrabarty

doi:10.1155/2013/342794

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 μg/mL, 0.67–149.4 μg/mL, and 0.42–7.6 μg/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.

Highlights

Mometasone Furoate (MF), (11β, 16α)-9, 21-dichloro11-hydroxy-16-methyl-3, 20-dioxopregna-1, 4-dien-17-yl 2-furoate (Figure 1(a)) is a topical corticosteroid; it has antiinflammatory, antipruritic, and vasoonstrictive properties
X-Terra C18 (150 × 4.6 mm, 5 μ) column with flow rate 1.5 mL/min and column temperature 50∘C were used in high performance liquid chromatography (HPLC) equipped with photo diode array detector
To reduce run time and improve MF peak shape, an attempt was made by increasing acetonitrile composition in mobile phase, which became buffer (0.2% v/v triethyl amine in water, pH 6.5 adjusted with glacial acetic acid) : acetonitrile (40 : 60 v/v)

Summary

Introduction

Mometasone Furoate (MF), (11β, 16α)-9, 21-dichloro11-hydroxy-16-methyl-3, 20-dioxopregna-1, 4-dien-17-yl 2-furoate (Figure 1(a)) is a topical corticosteroid; it has antiinflammatory, antipruritic, and vasoonstrictive properties. Mometasone inhibits the action of allergic reactions, eczema, and psoriasis that cause inflammation, redness, and swelling [1, 2]. Ketoconazole (KT), an imidazole derivative, chemically 1-[4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]ethan1-one (Figure 1(b)) is an antifungal agent with topical and systemic action and can be incorporated into several pharmaceutical forms. Methylparaben (MP) (Figure 1(c)) and its salts are most commonly used as preservatives for many years. To establish their effectiveness throughout the shelf life of the product, the actual concentrations of preservatives must be determined, as required by regulatory agencies [8]

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