Development of a Simple Extraction Procedure and an HPLC Method for the Determination of Delmopinol in a Challenging Rubbery Dental Chew.

Delmopinol hydrochloride (delmopinol) is widely used in oral hygiene products such as dental chews for preventing dental plaque buildup and gingivitis. This study aimed to develop a simple and inexpensive extraction method, followed by a stability-indicating reversed-phase HPLC (RP-HPLC) method for the determination of delmopinol from rubbery dental chews. The extraction method was optimized in terms of pH, temperature, solvents, repeatability, and reproducibility. Delmopinol was extracted from the rubbery dental chews using 6 N NaOH-MeOH (1 + 1, v/v) at 65°C. The delmopinol peak was eluted in about 7 min by gradient elution on a pH-stable (alkaline) Phenomenex Gemini-NX-C18 column (50 × 4.6 mm id, 110 Å, 3 µm particle size) maintained at 50°C. Mobile phase A was composed of aqueous 10 mM ammonium hydroxide and mobile phase B was acetonitrile. The analyte was monitored by UV detection at 220 nm with a flow rate of 2.0 mL/min. The method was successfully validated as per the current International Conference on Harmonization guidelines for delmopinol with respect to specificity, linearity (R2 >0.999), accuracy, precision, LOQ (2 µg/mL), LOD (0.6 µg/mL), and robustness. The reliability of the method was also demonstrated by batch analysis of 132 dental chews. A simple extraction method and RP-HPLC method were successfully developed and validated for the determination of delmopinol from rubbery dental chews. The overall method was demonstrated to be accurate, robust, specific, and stability-indicating. Therefore, the developed method is suitable and highly desirable for routine analysis of delmopinol in its finished drug products. © The Author(s) 2023. Published by Oxford University Press on behalf of AOAC INTERNATIONAL. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Citation

Jinyou Zhang, Abu M Rustum, Sarju Adhikari. Development of a Simple Extraction Procedure and an HPLC Method for the Determination of Delmopinol in a Challenging Rubbery Dental Chew. Journal of AOAC International. 2023 May 03;106(3):778-785

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PMID: 36610994

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