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Current Pharmaceutical Analysis

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ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

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Research Article

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

In Press, (this is not the final "Version of Record"). Available online 12 June, 2024
Author(s): Gamze Ergin Kızılçay*, Sıdıka Ertürk Toker and Dilek Matur
Published on: 12 June, 2024

DOI: 10.2174/0115734129293343240604061830

Price: $95

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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