A Review of Analytical Methods for Determination Bromhexine Hydrochloride in Pharmaceutical and Biological Samples

  • Meera Lad Shree Dhanvantary Pharmacy College
  • Vineet Jain Shree Dhanvantary Pharmacy College
  • Hasumati Raj Shree Dhanvantary Pharmacy College
Keywords: Bromhexine, UV Spectroscopic Method, Chromatography

Abstract

Bromhexine HCl (BRH)is a mucolytic agent used in the treatment of respiratory disorders associated with viscid or excessive mucus, chemically named 2-amino-3,5-dibromo-N-cyclohexyl-N-methyl benzenemethanamine hydrochloride. According to IUPAC it is 2,4-dibromo-6-[[cyclohexyl(methyl)amino]methyl] aniline hydrochloride. Because of its physiological importance, the drug has been quantified by exploiting its chemical  and physical properties. Bromhexine is a weak base and its precipitate out at pH value above 6. Bromhexine is a synthetic benzyl amine derivative ofvasicine. The different analytical methods used to quantify the drug as a single active pharmaceutical ingredient include flow injection analysis with ion selective electrodes, inductively coupled plasma mass spectrometry, electrokinetic chromatography, electrochemical oxidation at the glassy carbon electrode, liquid chromatography, liquid gas chromatography, GC with mass detection, and voltammetry. The drug has also been quantified in its combined formulations using HPLC, direct and derivative UV spectrophotometry.

Author Biographies

Meera Lad, Shree Dhanvantary Pharmacy College

Department of Quality Assurance,
Shree Dhanvantary Pharmacy College,
Kim, Gujarat, India

Vineet Jain, Shree Dhanvantary Pharmacy College

Department of Pharmacognosy,
Shree Dhanvantary Pharmacy College,
Kim, , India

Hasumati Raj, Shree Dhanvantary Pharmacy College

Department of Quality Assurance,
Shree Dhanvantary Pharmacy College,
Kim, Gujarat, India

References

1. L. Parvez, M. Vaidya, A. Sakhardande, S. Subburaj, and T. G. Rajagopalan, “Evaluation of antitussive agents in man,” Pulmonary Pharmacology, 1996, 9(5-6), 299–308.
2. D. M. Cobbin, F. M. Elliott, and A. S. Rebuck, “The mucolytic agent bromhexine (bisolvon) in chronic lung disease. A doubleblind crossover trial,” Australian and New Zealand Journal ofMedicine, 1971, 1(2), 137–140.
3. Indian Pharmacopoeia 1996 and Addendum 2000 (Government of India, Ministry of Health and Family welfare. Controller of publications. New Delhi, India).
4. British Pharmacopoeia, vol. 2, HMSO, London, UK, 1996.
5. S. S. Zarapker, R. V.Rele, and V. J. Doshi, “Simple spectrophotometricmethods for estimation of bromhexine hydrochloride,” Indian Drugs,1988, 26(1), 38–41.
6. M. I. R. M. Santoro, M. M. Dos Santos, and J. F. Magalhaes, “Spectrophotometric determination of bromhexine hydrochloride in pharmaceutical preparations,” Journal of the Associationof Official Analytical Chemists, 1984, 67(3), 532–534.
7. Denise C O, Karina T V, Alma L R V*, “Simultaneous Determination of Bromhexine and Amoxicillin in Pharmaceutical Formulations by Capillary Electrophoresis”, J. Mex. Chem. Soc, 2011, 55(2), 79-83.
8. Chemical land21.com/lifescience/phar/BROMHEXINE.htm
9. Drugsupdate.com/generic/view/745/Bromhexine
10. Abdel NaserZaid, “Formulation and stability evaluation of 1% w/v oral solution of Bromhexine hydrochloride for veterinary use”, The Islamic University Journal, 2007, 15(1), 13 -22.
11. tga.gov.au/rt/forms/otc-template-pi-bromhexine.rtf
12. The European Pharmacopoeia, 7th Edition,European Directorate for the Quality of Medicines & Health Care, 2011, Volume-II,1120-1121.
13. Liu Suying FS, Wong Kwok TX,“Bromhexine hydrochloride film content on High Performance Liquid Chromatography”, Research Papers Center.
14. Mehran J, Mohammad HN and Behrouz A, “Molecularly imprinted solid-phase extraction for the selective determination of Bromhexine in human serum and urine with high performance liquid chromatography”, Department of Chemistry, Amirkabir University of Technology, Tehran, Iran, 2009; 80(1), 133-138.
15. Amit K , Sanju N,“A validated high performance liquid chromatographic method for estimation of Bromhexine and terbutalinein bulk and tablet dosage forms” Pharmaceutical method, 2011, 2(4), 218-222.
16. Lalit VS*, Sanjaykumar BB, “Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Amoxicillin Trihydrate and Bromhexine Hydrochloride from Oily Suspension”, PharmaceuticaAnalyticaActa, 1(2), 1000107.
17. Satyanarayana PV, Murali M* and Venkateswara RP, “Simultaneous determination of Terbutaline and Bromhexine in Combined Pharmaceutical Dosage Form by RP-HPLC Method”, International Journal of ChemTech Research, 2012, 4(1), 240-246.
18. Shujuan L, Liang Z, Xia L, Feng Z and Shengxiang J*. “Simultaneous Determination of Bromhexine HCl and Baicalin in Chinese Compound Medicine by a Reversed-Phase Ion-Pair HPLC”, Journal of Food and Drug Analysis, 2004,12(4), 306-310.
19. EEndang S , Gunawan I, “TLC Densitometric Determination of Bromhexine Hydrochloride in Pharmaceuticals and Its Validation”, Journal of Liquid Chromatography & Related Technologies, 2005, 27(13), 2047-2056.
20. Rao Monica RP, Kumar M, Aghav S andSukreGirish, “ Development and Validation of HPTLC Method for Determination of Bromhexine Hydrochloride in Human Plasma”, Department of Pharmaceutics, AISSMS College of Pharmacy, Pune, 2012, 5(8), 1054-1057.
21. Susmitha K, Thirumalachary M and Venkateshwarlu G, “ Spectrophotometric Determination of Bromhexine HCl in Pure and Pharmaceutical Forms”,Department of Chemistry, Jawaharlal Nehru Technology University, Hyderabad 500085, India, 2013, 1-7.
22. Dhoka MV, Gawande VT and Joshi PP,“Simultaneous Estimation of Amoxicillin Trihydrate and Bromhexine Hydrochloride in Oral Dosage Forms by Spectrophotometric Method”, International Research Journal of Pharmacy, 2011, 2(3), 197-201.
23. Tantishaiyakul V, Poeaknapo C, Sribun P and Sirisuppanon K, “ Simultaneous Determination of Dextromethorphan HBr and Bromhexine HCl in tablets by First-Derivative Spectrophotometry”,Journal of Pharmaceutical and Biomedical Analysis, 1997, 17(1998), 237-243.
24. Dharmesh M, Avinash N,Mehul K, Ketan D and Shital F, “ Development And Validation Of Spectrophotometric Method For Simultaneous Estimation Of Bromhexine Hydrochloride And Phenylephrine Hydrochloride In Their Combined Pharmaceutical Dosage Form By Simultaneous Equation Method”Inventi Rapid: Pharm Analysis & Quality Assurance.
25. Wen Z, Fang F and Ya Wang,“Bioequivalence study of Bromhexine by liquid chromatography–electrospray ionization-mass spectrometry after oral administration of Bromhexine hydrochloride tablet”, Journal of Pharmaceutical and Biomedical Analysis, 2008, 48(4), 1206-1210.
26. Venkata R, RamanaR, Raghuveer S and Khadgapathi P,“Gas-liquid chromatographic and ion-pair high-performance liquid chromatographic determination of pseudoephedrine hydrochloride and Bromhexine hydrochloride in pharmaceuticals”, Analyst, 1987, 112(6), 871-874.
27. Denise CO, Karina TV, Alma L and Revilla V*,“Simultaneous Determination of Bromhexine and Amoxicillin in Pharmaceutical Formulations by Capillary Electrophoresis”, J. Mex. Chem. Soc, 2011, 55(2), 79-83.
28. QingqingJ, FeiNie&Jiuru Lu, “Chemiluminescence determination of bromhexine hydrochloride with morin as chemiluminescent reagent”, The journal of biological and chemical luminescene, 4jan 2008, 23(1), 32-36.
29. “Marketed products of brand name of bromhexine hydrochloride”, Available From: medguideindia.com.
Published
2014-11-01
How to Cite
[1]
Lad, M., Jain, V. and Raj, H. 2014. A Review of Analytical Methods for Determination Bromhexine Hydrochloride in Pharmaceutical and Biological Samples. PharmaTutor. 2, 11 (Nov. 2014), 35-41.