DEVELOPMENT OF A SPECTROPHOTOMETRIC METHOD FOR THE ASSAY OF BROMHEXINE HYDROCHLORIDE IN ITS PURE FORM AND IN ITS PHARMACEUTICAL PREPARATIONS USING DIAZOTIZATION - COUPLING REACTION
DOI:
https://doi.org/10.11113/jurnalteknologi.v87.23429Keywords:
Spectrophotometric, bromhexine hydrochloride, diazotization-coupling, 4-chlororesorcinol, azodyeAbstract
A simple, rapid, and accurate spectrophotometric method has been developed for determining bromhexine hydrochloride (BROH) in its pure form and pharmaceutical formulations. The method is based on the reaction of diazotized bromhexine hydrochloride (DBROH) with the organic reagent 4-chlororesorcinol (4CRC) in the presence of a sodium hydroxide basic medium. This reaction produces a stable, water-soluble orange-colored azo dye, which exhibits maximum spectral absorption at a wavelength of 455 nm.The method demonstrated high sensitivity, with a molar absorptivity of 43,548 L/mol•cm. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 0.322 µg/mL and 1.073 µg/mL, respectively. The proposed method was successfully applied to the analysis of bromhexine hydrochloride in pharmaceutical preparations, including syrups and tablets, showcasing its efficacy and reliability.
References
Bhagat, A. and Rachana, R. 2018. Bromhexine: A Comprehensive Review. Int J Bio Med Res. 9(3): 64559.
Talukdar, A., Sarkar, D. and Sarkar, D. 2023. Bromhexine: Into the Spotlight. In Viral, Parasitic, Bacterial, and Fungal Infections Academic Press. 719731.
Tolouian, R., Mulla, Z.D., Jamaati, H., Babamahmoodi, A., Marjani, M., Eskandari, R. and Dastan, F. 2023. Effect of Bromhexine in Hospitalized Patients with COVID-19. Journal of Investigative Medicine. 71(7): 691699. http://dx.doi.org/10.1136/jim-2020-001747.
Strózik , M., Strzebońska , M., Skiba, K. and Tatara , W., 2022. Development and Validation of the Analytical Methods for the Determination of Bromhexine Hydrochloride and Related Impurities in Novel Orodispersible Tablets. Acta Poloniae Pharmaceutica. 79(4). http://dx.doi.org/10.32383/appdr/152632.
British Pharmacopoeia. 2022. London: The Stationery Office. 340.
Lad, M. V., Jain, V. and Hasumati, R. 2014. A Review of Analytical Methods for Determination of Bromhexine Hydrochloride in Pharmaceutical and Biological Samples. PharmaTutor. 2(11): 3541.
Mostafa, E. 2023. Spectrophotometric Determination of Bromhexine HCl in Pure and Pharmaceutical Forms. J Mol Pharm Org Process Res. 11: 182. http://dx.doi.org/10.4172/2329-9053.1000182.
Kareem, N. K., Thani, M. Z. and Al-Rawi, K. F. 2022. New Microextraction Methods for the Evaluation of Bromhexine HCl in Pure and Pharmacological Formulations. Egyptian Journal of Chemistry. 65(4): 209219. https://dx.doi.org/10.21608/ejchem.2021.92380.4377.
Sultan, S. H. and Majed, Z. W. 2020. Spectrophotometric Determination of Bromhexine Hydrochloride by Diazotization and Coupling Method in Its Pharmaceutical Preparations. Iraqi Journal of Science. 21722181. https://dx.doi.org/10.24996/ijs.2020.61.9.3.
Mohammed, S. A. and Almukhtar, R. F. 2018. Indirect Spectrophotometric Method for Determination of Bromhexine-HCL in Pharmaceutical Preparations. Rafidain Journal of Science. 27: 116126.
Siddappa, K. and Hanamshetty, P. C. 2016. Spectrophotometric Quantitative Determination of Bromhexine Hydrochloride in Bulk and Pharmaceutical Dosage Form using PDEAB Reagent. Chemical Science Transactions. 5(3): 611318. https://dx.doi.org/10.7598/cst2016.1270.
Narayana, A., Rao, C. N. and Sivakumar, K. 2015. Spectrophotometric Determination of Bromhexine using Charge Transfer Complex Reaction. Indian Journal of Advances in Chemical Science. 3(2): 128132.
Rajan, V. 2015. Simultaneous UV-spectrophotometric Estimation of Bromhexine Hydrochloride and Salbutamol Sulphate by Area under Curve Method in Combined Dosage Form. Der Pharmacia Sinica.
Tantawy, M. A., Abdulla, S. A., Mohamed, O. Y. and Abou Al-Alamein, A. M. 2023. Normal-phase TLC and Gradient Reversed-phase HPLC for the Simultaneous Determination of Enrofloxacin and Bromhexine HCl in Presence of Two of Their Official Impurities. Journal of Chromatographic Science. 61(6): 546551.
Jain, V. and Sharma, M. C. 2016. Validated RP-HPLC Method for Determining the Levels of Bromhexine HCl, Chlorpheniramine Maleate, Dextromethorphan HBr and Guaiphenesin in Their Pharmaceutical Dosage Forms. Journal of Taibah University for Science. 10(1): 3845. https://doi.org/10.1016/j.jtusci.2015.02.019.
Rao, N. U. T. A. N. and Gawde, K. D. 2018. Method Development and Force Degradation Studies for Simultaneous Estimation of Salbutamol Sulfate, Etofylline and Bromhexine Hydrochloride in Pharmaceutical Dosage Form using Reversed-phase High-performance Liquid Chromatography Method. Asian J Pharm Clin Res. 11(8): 378382.
Joshi, H. V., Patel, J. K. and Patel, S. M. 2017. Development and Validation of Analytical Method for Simultaneous Estimation of Bromhexine HCl and Enrofloxacine in Combined Pharmaceutical Dosage Form. Eurasian Journal of Analytical Chemistry. 12(8).
Obeid, M., Allous, I. and Hirbali, J. 2016. Validated PR-HPLC Method for Determination of Bromhexine Hydrochloride, Terbulaine Sulfate and Guaiphenesine in Pharmaceutical Dosage Forms. Asian J. Pharm. Anal. Med. Chem. 4: 6973.
Kong, D., Han, L., Wang, Z., Jiang, L., Zhang, Q., Wu, Q., Su, J., Lu, C. and Chen, G. 2019. An Electrochemical Sensor based on Poly (procaterol hydrochloride)/carboxyl Multi-Walled Carbon Nanotube for the Determination of Bromhexine Hydrochloride. RSC Advances. 9(21): 1190111911. http://dx.doi.org/10.1039/c8ra08510b.
Mika, J., Moreira, J. C., Nemeckova, A., Zima, J., Barek, J. and Dejmkova, H. 2015. Determination of Bromhexine at a Glassy Carbon Paste Electrode using Differential Pulse Voltammetry and Flow Injection Analysis with Amperometric Detection. Monatshefte für Chemie-Chemical Monthly. 146: 12111215.
Abdel-Ghani, N. T., Issa, Y. M. and Ahmed, H. M. 2006. Potentiometric Flow Injection Analysis of Bromhexine Hydrochloride and Its Pharmaceutical Preparation using Conventional and Coated Wire Ion-selective Electrodes. Scientia Pharmaceutica. 74(3): 121135.
Cruz Oliva, D., Torres Vélez, K. and Revilla Vázquez, A. L. 2011. Simultaneous Determination of Bromhexine and Amoxicillin in Pharmaceutical Formulations by Capillary Electrophoresis. Journal of the Mexican Chemical Society. 55(2): 7983.
Taha, E. A. 2023. Validated ATR-FTIR Method For Quantitative Simultaneous Estimation of Terbutaline Sulfate, Guaiphenesin and Bromhexine Hydrochloride, in Bulk and Pharmaceutical Dosage Form. Egyptian Journal of Chemistry. 66(12): 155161. https://doi.org/10.21608/ejchem.2023.160569.6921.
Jiang, Q., Nie, F. and Lu, J. 2008. Chemiluminescence Determination of Bromhexine Hydrochloride with Morin as Chemiluminescent Reagent. Luminescence. 23(1): 3236.
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