JUN 2014 ARTICLE LIST >>
PharmaTutor (June- 2014)
ISSN: 2347 - 7881
Received On: 06/04/2014; Accepted On: 13/04/2014; Published On: 01/06/2014
AUTHORS: Dharmesh R. Mevada*, Krutika Bhalodiya, Brijesh Maniar, Ketan Dadhania, Shital Faldu
Department of Quality Assurance,
Smt. R. D. Gardi B. Pharmacy College,
Rajkot, Gujarat, India
*dharmeshmevada89@gmail.com
ABSTRACT:
UV Spectrophotometric method has been developed for simultaneous estimation of Bromhexine HCl (BHX) and Phenylephrine HCl (PLE) in bulk drug and in their combined Pharmaceutical dosage form by first order derivative. This method utilizes methanol as a common solvent and λmax of BHX and PLE selected for analysis was found to be at 241 nm (at ZCP of PLE) and 233 nm (at ZCP of BHX) respectively. Linearity was observed in the concentration range of 5-30 μg/ml for BHX (r2 = 0.999) and 10-60 μg/ml for PLE (r2 = 0.998). The accuracy and precision were determined and found to comply with ICH guidelines. This method showes good reproducibility and recovery with % RSD in the desired range. Developed method was applied for marketed formulation. The results were found to be within acceptance criteria according to ICH guideline. This method was simple, rapid, accurate, Precise and sensitive.
How to cite this article: DR Mevada, K Bhalodiya, B Maniar, K Dadhania, S Faldu; Development and Validation of First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Bromhexine Hydrochloride and Phenylephrine Hydrochloride in their Combined Pharmaceutical Dosage Form; PharmaTutor; 2014; 2(6); 132-138
[ABSTRACT WITH CITATION] [VIEW AS HTML]
REFERENCES:
1.The Merck Index, An Encyclopedia of Chemicals, Drugs, and Biologicals, Merck & Co, Inc, Whitehouse Station, NJ: 2006. pp 233,1307.
2.Sweetman SC. Martindale: The complete drug reference, pharmaceutical press, 33rd edn, London: The pharmaceutical press, pp 1115,1126.
3.Rang HP, Dale MM, and Ritter JM, Pharmacology, 6 th Edn, , New York: Churchill Livingstone 2007. pp 294-315.
4.Tripathi KD, Essential of Medical Pharmacology, 6th Edn, New Delhi: Jaypee Brothers Medical Publishers (P) Ltd, 2008. pp 120-125, 213-214.
5.Dr.Vikas Seth,Clasification of Drugs with Drug Choice,3rd Edn, New Delhi: Aditya Medical Publishers, 2010. pp 41,99.
6.Indian Phamacopoeia, Volume-I & Volume-II, Government of India, Ministry of Health and Family Welfare, Published by The Indian Pharmacopoeia Commission, Ghaziabad. 2010, pp 921,1899.
7.The United States Pharmacopoeia-30, NF-25, Asian edition, Rockville, MD: The US Pharmacopoeial Convention, Inc. 2004, pp 1471.
8.British Pharmacopoeia, Volume I-II, London: The Department of Health,: HMSO Publication; 2009, pp 770, 4683.
9.For marketed preparation:
medlineindia.net/drugprice/index.asp
medguideindia.net/druginformation/BromhexineHCl,Phenylephrin HCl
10.Chatwal GR, Anands, Ultraviolet-Spectroscopy, Instrumental Methods of Chemical Analysis, Mumbai: Himalaya Publishing House, 2000. pp 180-198.
11.Sharma S, Sher P, Badve S, Atmaram PP. Recent advances in Spectroscopic technique, 6th Edn, AAPS Pharm Sci Tech 2005. E 618-E 625.
12.Backett AH, and Stenlake JB, Practical Pharmaceutical Chemistry, First Edition, Reprint, New Delhi: CBS Publishers and Distributors, 2004. pp 275 – 325.
13.Skoog DA, Heller TJ, Nieman TA, Principal of Instrumental Analysis, Saunder college publishing, NewYork, 2007, pp 834-845.
14.Mendham J, Denny JD, Barner & Thomas MJK, Vogel’s Text book of Quantitative Chemical Analysis, 6th Edn, , India: Dorling Kindersley, 2007. pp 717-756.
15.International Conference on Harmonization of Technical Requirments for Registration of Pharmaceutical for Human use. Validation of analytical proceure: Text book and Methodology ICH Q2 (R1) 2005.
16.Panda SK and Sharma AK,“Simultaneous Spectrophotometric estimation of Phenylpropanolamine Hcl,Bromhexine Hcl,And Chlorpheniramine Maleate.” International Journal of Pharmaceutical science, 1999, 61(2), 61-64.
17.Dhoka MG, Gawade VD and Joshi PV, “Spectrophotometric Method For Simultaneous Determination Of Amoxicillin trihydrate And Bromhexine hydrochloride in oral Dosage Form.” International Journal of Pharmacy and Pharmaceutical Science, 2010, 2(3): 129-134.
18.Ivana SV, Goran NI and Vladimir BC, “Development and Validation Of Spectrophotometric method for Phenylephrine hcl estimation in nasal drop formulations.” Macedonian Journal of Chemistry and chemical engineering, 2008, 27(2): 129-133.
19.Tantishaiyakul V, Poeaknapo C, Sribun P, Sirisuppanon K .” Simultaneous determination of dextromethorphan HBr and bromhexine HCl in tablets by first-derivative spectrophotometry.” Journal of pharmaceutical and biomedical analysis, 1998, 3(8): 237-243.
.png)
