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

  • Mostafa M. Baker
  • Dina Salah El-KafrawyEmail author
  • Magdi M. Abdel-Khalek
  • Tarek S. Belal
Original

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.

Graphic abstract

Keywords

HPLC–DAD Stability indicating Sertaconazole nitrate Sorbic acid Methylparaben 

Notes

Compliance with Ethical Standards

Conflict of interest

The authors declare that there are no conflicts of interest.

Research involving human or animal participants

This article does not contain any studies with human participants or animals performed by any of the authors.

Supplementary material

10337_2019_3832_MOESM1_ESM.pdf (137 kb)
Supplementary material 1 (PDF 137 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Mostafa M. Baker
    • 1
  • Dina Salah El-Kafrawy
    • 2
    Email author
  • Magdi M. Abdel-Khalek
    • 2
  • Tarek S. Belal
    • 3
  1. 1.Methodology DepartmentPharco Pharmaceuticals CompanyAlexandriaEgypt
  2. 2.Pharmaceutical Chemistry Department, Faculty of PharmacyUniversity of AlexandriaAlexandriaEgypt
  3. 3.Pharmaceutical Analytical Chemistry Department, Faculty of PharmacyUniversity of AlexandriaAlexandriaEgypt

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