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A Highly Selective Stability-Indicating HPLC Method for Simultaneous Estimation of Sertaconazole with Two Coformulated Preservatives in Pharmaceutical Dosage Forms

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Abstract

The present investigation deals with the development of a validated stability-indicating HPLC–DAD method for the simultaneous determination of sertaconazole nitrate (SN) and two coformulated preservatives: sorbic acid (SA) and methylparaben (MP). The analytes were subjected to stress conditions: acidic and alkaline hydrolysis, oxidation, and photo and thermal degradation. The suggested technique offers high resolution among the degradation products and the analytes. Moreover, the adopted method proved to be highly specific upon resolution of the three analytes from 14 different pharmaceutical compounds related to antifungals, preservatives, and antioxidants. The obtained results conform to the accelerated stability study of the cream form upon storage for 6 months at 40 °C and 75% RH. The HPLC procedure was validated with respect to system suitability, linearity, ranges, precision, accuracy, specificity, robustness, detection, and quantification limits. The linearity ranges for SN, MP, and SA were 1–200, 1–250, and 0.5–100 μg mL−1, respectively, with correlation coefficients > 0.9999. The developed method was successfully applied for the assay of sertaconazole cream, powder, and spray dosage forms.

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Authors and Affiliations

  1. Methodology Department, Pharco Pharmaceuticals Company, Alexandria, Egypt

    Mostafa M. Baker

  2. Pharmaceutical Chemistry Department, Faculty of Pharmacy, University of Alexandria, Elmessalah, Alexandria, 21521, Egypt

    Dina Salah El-Kafrawy & Magdi M. Abdel-Khalek

  3. Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, University of Alexandria, Elmessalah, Alexandria, 21521, Egypt

    Tarek S. Belal

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  1. Mostafa M. Baker
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  2. Dina Salah El-Kafrawy
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  3. Magdi M. Abdel-Khalek
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  4. Tarek S. Belal
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Correspondence to Dina Salah El-Kafrawy.

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Baker, M.M., El-Kafrawy, D.S., Abdel-Khalek, M.M. et al. A Highly Selective Stability-Indicating HPLC Method for Simultaneous Estimation of Sertaconazole with Two Coformulated Preservatives in Pharmaceutical Dosage Forms. Chromatographia 83, 191–203 (2020). https://doi.org/10.1007/s10337-019-03832-8

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  • DOI: https://doi.org/10.1007/s10337-019-03832-8

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