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Development of a Simple Extraction Procedure and an HPLC Method for the Determination of Delmopinol in a Challenging
Jinyou Zhang1, Abu M Rustum1, Sarju Adhikari1
1Global Pharmaceutical Technique Support, Boehringer Ingelheim Animal Health (BIAH) USA, 631 US Route 1 South, North Brunswick, NJ 08902, USA.
Background:
Delmopinol hydrochloride (delmopinol) is widely used in oral hygiene products such as dental chews for preventing dental plaque buildup and gingivitis.
Objective:
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.
Methods:
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.
Results:
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.
Conclusion:
A simple extraction method and RP-HPLC method were successfully developed and validated for the determination of delmopinol from rubbery dental chews.
Highlights:
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.
