0.60
CiteScore
0.186
SJR
0.447
SNIP
CC-BY 4.0
 
 

Development and Validation of Analytical Method for Simultaneous Estimation of Bromhexine HCl and Enrofloxacine in Combined Pharmaceutical Dosage Form

Hirak V. Joshi 1  ,  
Shah Ujash A. 1,  
J. K. Patel 1,  
 
1
Nootan Pharmacy College, Sakalchand Patel University, Visnagar, Gujarat, INDIA
Eurasian J Anal Chem 2017;12(8):1631–1638
Online publish date: 2017-10-26
Publish date: 2017-10-26
KEYWORDS:
ABSTRACT:
A simple, accurate, precise RP-HPLC method has been developed and validated for the simultaneous estimation of Bromhexine HCl and Enrofloxacin in their combined tablet dosage form. The combination used for the Separation is ENROLIQ-B. Separation was performed on a C18 column [Hypersil BDS C18 column, 250 x 4.6 mm], with 0.05 M KH2PO4 Buffer pH 6: Methanol: Triethylamine (70:30:0.1 %v/v/v) as a mobile phase and flow rate was kept at 1 ml/min. Good sensitivity was found with UV detection at 261.00 nm. After method development the interference with the active compounds and excipients, repeatability and linearity were investigated. ReBROMtion times were found to be 3.190 and 5.067 min. respectively, for BROM and ENR. The method was validated over the analytical range from 1.5-4.5μg/ml for BROM (r2=0.998) and 20-60 μg/ml for ENR (r2=0.999). This method showed good reproducibility and recovery with %RSD in the desired range. The proposed method can be successfully applied for the routine analysis of both drugs in their combine dosage form.
CORRESPONDING AUTHOR:
Hirak V. Joshi   
Department of Quality Assurance, Nootan Pharmacy College, Sakalchand Patel University, Visnagar, Gujarat, India
 
REFERENCES (20):
1. Tripathi, K. D. (2003). Essential of Medical Pharmacology (6th Edn.). New Delhi: Jaypee Publication.
2. Khan, C. M. (2005). The Merck Veterinary Manual (9th Edn.). Whitehouse Station, NJ, USA: Merck.
3. Richard, F., & Luigix, C. (2008). Lippioncott’s Illustrated Reviews Pharmacology (4th Edn.). Lippincott Williams & Wilkins.
4. Indian Pharmacopoeia. (2010). Government of India ministry of health and family wealthfare. Ghaziabad: The Indian phamacopoeial commission, II, pp. 1090-1094.
5. British Pharmacopoeia. Vol. 1. (2009). United Kingdom: The Stationary office on the behalf of MHRA, pp. 280–281.
6. The United States Pharmacopoeia (USP). (2014). USP 37, NF 32, United States Pharmacopeial Convention. Rochville, Md, USA.
7. Rele, R. V. (2015). Simultaneous determination of Bromhexine hydrochloride and salbutamol sulphate in pharmaceutical dosage by reverse phase high performance liquid chromatography. Scholar Research Library, 7(3), 157-161.
8. Jayalakshmi, B., Ramesh, J., Kalpana, T. N., & Vijayamirtharaj, R. (2010). Analytical method development and validation of simultaneous determination of Diphenhydramine HCl, Guaiphenesin and Bromhexine HCl in liquid dosage form by RP-HPLC technique. Journal of Pharmaceutical Research, 3(12), 2868-73.
9. Jain, V. H., & Sharma, M. C. (2016). Validated RP-HPLC method for determining the levels of BromhexineHCl, Chlorpheniramine maleate, Dextromethorphan HBr and Guaiphenesin in their pharmaceutical dosage forms. Journal of Taibah University 2016, X, 38-45.
10. Porel, A., Sanjukta, H., & Kundu, A. (2011). Stability-indicating HPLC Method for Simultaneous Determination of Terbutaline Sulphate, Bromhexine Hydrochloride and Guaifenesin. Indian Journal of Pharmaceutical Science, 73(1), 46-56.
11. Dhoka, M., Gawande, V., & Joshi, P. (2010). High performance liquid chromatographic method for determination of Amoxicillin trihydrate and Bromhexine hydrochloride in oral dosage forms. International. Journal of Pharmacy and Pharmaceutical Science, II(1), 129-130.
12. Chaudhary, A. B., Bhadani, S. M., & Shah, C. M. (2015). Development and validation of RP-HPLC method for simultaneous estimation of Bromhexinehydrochloride, Guaiphenesin and Chlorpheniramine maleate in tablet. World Journal of Pharmacy and Pharmaceutical Science, IV(05), 1679-1694.
13. Sheikh, S. N., & Asgar, S. A. (2013). A validated and stability indicating high performance thin layer chromatographic method for the simultaneous estimation of Terbutaline sulphate, Guaiphenesin and Bromhexine HCl in pharmaceutical formulation. International Journal of Pharmaceutical Science and Research, 3(1), 200- 210.
14. Chakravarthy, A. V., Sailaja, B. B., & Kumar, A. P. (2015). Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms. Journal of Analytical methods in chemistry, 15(2), 180-187.
15. Jakubowski, P., Jaroszewski, J. J., Grabowski, T., Markiewicz, W., & Maslanka, T. (2010). Determination of Enrofloxacin in chicken plasma by high performance liquid chromatography for pharmacokinetic studies. Acta Vete (Beograd), 60(5-6), 563-572.
16. Bittencourt, C. F., & Morsch, L. M. (2002). Determination of Enrofloxacin. Journal of Pharmaceutical and Biomed. Analysis, (6), 1195-1199.
17. Tauber, V., Elena, P., & Chiurciu, V. (2015). Development and validation of HPLC method for the determination of Oxytetracycline and Enrofloxacin in veterinary formulations. Medica. Veternary Drug, 9(2), 65-69.
18. Beckett, A. H., & Stenlake, J. B. (2002). In practical pharmaceutical chemistry (4th Edn.), pp 275-305, 285-297.
19. ICH. (2005). Q2 (R1), harmonized tripartite guideline, validation of analytical procedures: text and methodology, In Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
20. Center for Drug Evaluation and Research (CDER). (1994). Reviewer Guidance: Validation of Chromatographic Methods. CMC, 3.
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