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Current Pharmaceutical Analysis

Author(s): Gamze Ergin Kızılçay*, Sıdıka Ertürk Toker and Dilek Matur

DOI: 10.2174/0115734129293343240604061830

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Development and Validation of New HPLC Method for the Determination of Imidazolidinyl Urea in Topical Formulation

  • * (Excluding Mailing and Handling)

Abstract

Introduction: In this study, a new, simple, selective, and fast liquid chromatographic method has been developed and validated for the determination of imidazolidinyl urea used as an anti-microbial agent in topical formulation.

Method: The developed HPLC method using a diode array detector for the determination of imidazolidinyl urea was applied to the topical formulation. Imidazolidinyl urea in the sample was analyzed in the cyano column (250 x 4,6 mm, 5 μm i.d.) under chromatographic conditions, where the flow rate was determined as 1.0 mL/min. The column oven was 40.0°C, and imidazolidinyl urea was detected at 210 nm. Isocratic application of acetonitrile-water (25:75, v/v) was used as the mobile phase system. The validation of the developed method was performed according to the International Conference on Harmonisation guidelines Q2 (R1).

Result: The linearity range of the imidazolidinyl urea was 0.050-0.150 mg/mL, and the limits of detection and quantification were calculated to be 62.5x10-6 mg/mL and 125x10-6 mg/mL, respectively. Assay recovery and precision of imidazolidinyl urea from topical formulation at 0.050, 0.100, and 0.125 mg/mL concentrations were evaluated. The mean recoveries for imidazolidinyl urea in the topical formulation were calculated as 98.857-104.560%.

Conclusion: The validated method was successfully applied to the determination of imidazolidinyl urea in a topical formulation. The proposed method is reproducible and reliable and can be used safely for routine analysis.

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