SIMULTANEOUS DETERMINATION OF BENZYDAMINE HYDROCHLORIDE, METHYLPARABEN AND PEPPERMINT OIL IN A SPRAY DOSAGE FORM BY GAS CHROMATOGRAPHY Original Article VASYL A. CHORNYI 1 , VICTORIYA A. GEORGIYANTS 2 , SVITLANA N. GUREYEVA 1 , OLGA V. CHORNA 3 1 JSK “Farmak”, Kiev, Ukraine, 2 Department of Pharmaceutical Chemistry, National Pharmaceutical University, Kharkov, Ukraine, 3 Received: 03 Mar 2019, Revised and Accepted: 23 Sep 2019 Department of Toxicology, Medical Academy of Postgraduate Education, Kharkov, Ukraine Email: vasylcherniy@gmail.com 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. Keywords: Benzydamine hydrochloride, Methylparaben, Peppermint oil, Menthol, Gas chromatography, Method development, Validation © 2019 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) DOI: http://dx.doi.org/10.22159/ijap.2019v11i6.32918 INTRODUCTION 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. Fig. 1: Chemical structure of benzydamine hydrochloride Methylparaben is a common antimicrobial preservative which is widely used in compositions with benzydamine hydrochloride for prevention growth of microbiological organisms in multiple used preparations, such as oral solutions, nasal and oral sprays and others [3-5]. Fig. 2: Chemical structure of methylparaben Peppermint oil is obtained from the leaves of the perennial herb, Mentha piperita L. and M. arvensis var. piperascens a member of the Labiatae family. It is a colorless, pale yellow or pale greenish-yellow liquid having characteristic odor and taste followed by a sensation of cold, freely soluble in ethanol (70%) [6, 7]. Peppermint oil is used for the treatment of digestive disorders and nervous system actions because of its antitumor and antimicrobial properties, chemoprevention potential, its renal actions, antiallergenic effects, and also for lessening cramping, digestive complaints, anorexia, nausea and diarrhea [8-11]. 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 (max. 0.2%),menthol (30.0-55.0%), pulegone (max. 4.0%) and carvone (max. 1.0%). The ratio of cineole content to limonene content should be minimum two [12]. Fig. 3: Chemical structure of methol Contemporary requirements of quality control laboratories match principles of green chemistry, which imply development, and further implementation of rapid analyzes for quality control [13-18]. Consequently, analytical method development of new drug products requires a thorough assessment of simultaneous determination of all substances to be analyzed by one injection, prioritizing rapid methods, which at the same time are less harmful to the International Journal of Applied Pharmaceutics ISSN- 0975-7058 Vol 11, Issue 6, 2019