Abstract
Objective: To develop and validate an analytical procedure for simultaneous determination of benzydamine hydrochloride, methylparaben and peppermint oil in a spray dosage form by gas chromatography method (GC).
 Methods: The analytical method was conducted on Agilent 7890 gas chromatograph, equipped with HP-5 capillary column with helium as a mobile phase, split/splitless injector and flame ionization detector and an auto injector. Validation parameters, such as selectivity, linearity, precision, accuracy and, robustness were estimated.
 Results: A method for simultaneous determination of benzydamine hydrochloride, methylparaben and peppermint oil in a spray dosage form by GC was developed. The retention time of menthol (marker substance of peppermint oil) methylparaben and benzydamine hydrochloride, was 5.0, 9.2, and 19.4 respectively. Relative standard deviation (RSD)% for precision was 0.24, 0.13 and 0.12 respectively. The linearity of the method for given analytes was estimated in a concentration range of 80-120% to a nominal concentration with the respective correlation coefficients of more than 0.999. Accuracy of the method was within 98-102% for all analytes.
 Conclusion: The developed analytical procedure meets the acceptance criteria of validation parameters and can be used in quality control laboratories for determination of benzydamine hydrochloride, methylparaben and peppermint oil in a spray dosage form.
Highlights
Benzydamine hydrochloride is an active pharmaceutical substance, which is widely used for the dosage forms applied for the treatment of inflammatory diseases of the oral cavity
Benzydamine hydrochloride reference standard and methylparaben reference standards were purchased as the Brittish Pharmacopeia standards
Benzydamine dosage form, which contained peppermint oil and methylparaben was kindly provided by JSK “Farmak”
Summary
Benzydamine hydrochloride is an active pharmaceutical substance, which is widely used for the dosage forms applied for the treatment of inflammatory diseases of the oral cavity. It exhibits analgesic and antipyretic properties [1, 2] and represented in finished dosage forms such as Tantum Verde, solution for oral treatment, Diflam, oral spray, Tantum Rosa, solution and many others. Piperascens a member of the Labiatae family. According to International Pharmacopea, pepermint oil contains: limonene (1.0-5.0%), cineole (3.5-14.0%), menthone (14.0-32.0%), menthofuran (1.0-9.0%), isomenthone (1.5-10.0%), menthyl acetate (2.8-10.0%), isopulegol The ratio of cineole content to limonene content should be minimum two [12]
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