SIMULTANEOUS DETERMINATION OF BENZYDAMINE HYDROCHLORIDE, METHYLPARABEN AND PEPPERMINT OIL IN A SPRAY DOSAGE FORM BY GAS CHROMATOGRAPHY

VASYL A. CHORNYI; VICTORIYA A. GEORGIYANTS; SVITLANA N. GUREEVA; OLGA V. CHORNA

doi:10.22159/ijap.2019v11i6.32918

Authors

VASYL A. CHORNYI JSK “Farmak”, Kiev, Ukraine
VICTORIYA A. GEORGIYANTS Department of Pharmaceutical Chemistry, National Pharmaceutical University, Kharkov, Ukraine
SVITLANA N. GUREEVA JSK “Farmak”, Kiev, Ukraine
OLGA V. CHORNA Department of Toxicology, Medical Academy of Postgraduate Education, Kharkov, Ukraine

DOI:

https://doi.org/10.22159/ijap.2019v11i6.32918

Keywords:

Benzydamine hydrochloride, Methylparaben, Peppermint oil, Menthol, Gas chromatography, Method development, Validation

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.

Downloads

Download data is not yet available.

References

Anand JS, Glebocka ML, Korolkiewicz RP. Recreational abuse with benzydamine hydrochloride (tantum rosa). Clin Toxicol (Phila) 2007;45:198-9.

Kuriyama A, Aga M, Maeda H. Topical benzydamine hydrochloride for prevention of postoperative sore throat in adults undergoing tracheal intubation for elective surgery: a systematic review and meta-analysis. Anaesthesia 2018;73:889-900.

Thompson JE. Antioxidants. Chapter 16. In: Thompson JE. A practical guide to contemporary pharmacy practice. 3rd ed. Lippincott Williams and Wilkins; 2009. p. 203-2015.

Johnson R, Steer R. Methylparaben monograph. In: Rowe RC, Sheskey PJ, Weller PJ. editors. Handbook of pharmaceutical excipients. 5th ed. Pharmaceutical Press; 2006. p. 466-70.

Boukarim C, Abou Jaoude S, Bahnam R, Barada R, Kyriacos S. Preservatives in liquid pharmaceutical preparations. Drug Test Anal 2009;1:146-8.

Haber SL, El-Ibiary SY. Peppermint oil for treatment of irritable bowel syndrome. Am J Health Syst Pharm 2016;73:22-6.

Natural standard: the authority on integrative medicine; 2014. https://naturalmedicines. therapeuticresearch.com. [Last accessed on 01 Feb 2019]

Loolaie M, Moasefi N, Rasouli H, Adibi H. Peppermint and its functionality: a review. Arch Clin Microbiol 2017;8:54.

Keifer D, Ulbricht C, Abrams TR, Basch E, Giese N. Peppermint (mentha xpiperita) an evidence-based systematic review by the natural standard research collaboration. J Herb Med 2008;7:91-143.

Saeidnia S, Gohari AR, Yassa N, Shafiee A. Composition of the volatile oil of achillea conferta dc. from Iran. DARU J Faculty Pharm 2005;13:34-6.

Ghori SS, Ahmed MI, Arifuddin M, Khateeb MS. Evaluation of analgesic and anti-inflammatory activities of formulation containing camphor, menthol and tymol. Int J Pharm Pharm Sci 2015;8:271-4.

The International Pharmacopoeia. 8th ed. Available from: http://lib.njutcm.edu.cn/yaodian/ep/EP5.0/16_monographs/monographs_l-p/Peppermint%20oil.pdf. [Last accessed on 01 Feb 2019]

Koel M, Kaljurand M. Application of the principles of Green chemistry in analytical chemistry. Pure Appl Chem 2006;78:1993-2002.

Eldin AB, Ismaiel OA, Hassan WE, Shalaby AA. Green analytical chemistry: opportunities for pharmaceutical quality control. J Anal Chem 2016;71:861-71.

Bhandari M, Raj S. Practical approach to green chemistry. Int J Pharm Pharm Sci 2017;9:10-26.

Dhir NK, Joshi M, Kaur V. Improved analytical method for estimation of essential oil in drug ointment through rapid static chromatography headspace for quality control analysis. Asian J Pharm Clin Res 2018;11:290-4.

Kavetsou E, Detsi A. Ionic liquids as solvents and catalysts for the green synthesis of coumarins. J Crit Rev 2016;3:50-5.

Rode DM, Rao NN. A review on development and validation of stability indicating HPLC methods for analysis of acidic drugs. Int J Curr Pharm Res 2019;11:22-33.

ICH harmonized tripartite guideline. Validation of analytical procedures text and methodology Q2 (R1); 2005. Available from: http://https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf. [Last accessed on 01 Feb 2019]

Sharma S, Goyal S, Chauhan K. A review on analytical method development and validation. Int J Appl Pharm 2018;10:8-15.

Carlucci G, Iuliani P, Federico LD. Simultaneous determination of benzydamine hydrochloride and five impurities in an oral collutory as a pharmaceutical formulation by high-performance liquid chromatography. J Chromatogr Sci 2010;48:854-9.

El-Didamony AM. Spectrophotometric determination of benzydamine HCl, levamisole HCl and mebeverine HCl through ion-pair complex formation with methyl orange. Spectrochimica Acta A Mol Biomol Spect 2008;69:770-5.

Sharma D, Singh R, Garg R. Development and validation of stability indicating UV spectro-photometric method for the estimation of benzydamine hydrochloride in bulk and in pharmaceutical dosage form: a novel analytical technique for conducting in vitro quality control tests. Int J Pharm Sci Res 2018;9:678-86.

Dinç Zor ŞD, Aksu Donmez O. A facile HPLC-PDA method for simultaneous determination of paracetamol, methyl paraben, sunset yellow, and carmosine in oral suspensions. JOTCSA 2018;5:763-74.

Baranowska I, Wojciechowska I, Solarz N, Krutysza E. Determination of preservatives in cosmetics, cleaning agents and pharmaceuticals using fast liquid chromatography. J Chromatogr Sci 2014;52:88-94.

Wolf S. Stability testing of mint oils through gas chromatography analysis. Honor. Theses 2007;733. Available from: https://www.scholarworks.wmich.edu/honors_theses/733/. [Last accessed on 01 Feb 2019].