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Sci. Pharm.
Volume 81
Issue 4
10.3797/scipharm.1303-22
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Article

Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Phenoxyethanol, Methylparaben, Propylparaben, Mometasone Furoate, and Tazarotene in Topical Pharmaceutical Dosage Formulation

by
Chinmoy ROY
1,2,* and
Jitamanyu CHAKRABARTY
2
1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500090, Andhra Pradesh, India
2
Department of chemistry, National Institute of Technology, Durgapur-713209, West Bengal, India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2013, 81(4), 951-968; https://doi.org/10.3797/scipharm.1303-22
Submission received: 26 March 2013 / Accepted: 4 June 2013 / Published: 4 June 2013
Versions Notes

Abstract

A stability-indicating RP-HPLC method has been developed and validated for the simultaneous determination of phenoxyethanol (PE), methylparaben (MP), propylparaben (PP), mometasone furoate (MF), and tazarotene (TA) in topical pharmaceutical dosage formulation. The desired chromatographic separation was achieved on the Waters X-BridgeTM C18 (50×4.6mm, 3.5μ) column using gradient elution at 256 nm detection wavelength. The optimized mobile phase consisted of 0.1%v/v orthophosphoric acid in water as solvent-A and acetonitrile as solvent-B. The method showed linearity over the range of 5.88–61.76 μg/mL, 0.18–62.36 μg/mL, 0.17–6.26 μg/mL, 0.47–31.22 μg/mL, and 0.44–30.45 μg/mL for PE, MP, PP, MF, and TA, respectively. The recovery for all of the components was in the range of 98-102%. The stability-indicating capability of the developed method was established by analysing the forced degradation samples, in which the spectral purity of PE, MP, PP, MF, and TA along with the separation of degradation products from the analyte peaks was achieved. The proposed method was successfully applied for the quantitative determination of PE, MP, PP, MF, and TA in a cream sample.
Keywords: Mometasone Furoate; Tazarotene; Phenoxyethanol; Parabens; Chromatography; Degradation; RP-HPLC Mometasone Furoate; Tazarotene; Phenoxyethanol; Parabens; Chromatography; Degradation; RP-HPLC

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MDPI and ACS Style

ROY, C.; CHAKRABARTY, J. Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Phenoxyethanol, Methylparaben, Propylparaben, Mometasone Furoate, and Tazarotene in Topical Pharmaceutical Dosage Formulation. Sci. Pharm. 2013, 81, 951-968. https://doi.org/10.3797/scipharm.1303-22

AMA Style

ROY C, CHAKRABARTY J. Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Phenoxyethanol, Methylparaben, Propylparaben, Mometasone Furoate, and Tazarotene in Topical Pharmaceutical Dosage Formulation. Scientia Pharmaceutica. 2013; 81(4):951-968. https://doi.org/10.3797/scipharm.1303-22

Chicago/Turabian Style

ROY, Chinmoy, and Jitamanyu CHAKRABARTY. 2013. "Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Phenoxyethanol, Methylparaben, Propylparaben, Mometasone Furoate, and Tazarotene in Topical Pharmaceutical Dosage Formulation" Scientia Pharmaceutica 81, no. 4: 951-968. https://doi.org/10.3797/scipharm.1303-22

APA Style

ROY, C., & CHAKRABARTY, J. (2013). Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Phenoxyethanol, Methylparaben, Propylparaben, Mometasone Furoate, and Tazarotene in Topical Pharmaceutical Dosage Formulation. Scientia Pharmaceutica, 81(4), 951-968. https://doi.org/10.3797/scipharm.1303-22

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