It is the cache of ${baseHref}. It is a snapshot of the page. The current page could have changed in the meantime.
Tip: To quickly find your search term on this page, press Ctrl+F or ⌘-F (Mac) and use the find bar.

Simultaneous UV spectrophotometric estimation of ambroxol hydrochloride and levocetirizine dihydrochloride Prabu S L, Shirwaikar A A, Shirwaikar A, Kumar C D, Kumar G A - Indian J Pharm Sci
Indian Journal of Pharmaceutical Sciences
Users online: 118
Scientific Publication of the Indian Pharmaceutical Association
Home Email this page Print this page Bookmark this page Decrease font size Default font size Increase font size
The Journal Search Current Issue Archives Instructions Online submission Login  


 
SHORT COMMUNICATION
Year : 2008  |  Volume : 70  |  Issue : 2  |  Page : 236-238
Simultaneous UV spectrophotometric estimation of ambroxol hydrochloride and levocetirizine dihydrochloride


1 Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal-576 104, India
2 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal-576 104, India
3 Department of Pharmacognosy, Manipal College of Pharmaceutical Sciences, Manipal-576 104, India

Date of Submission 13-Dec-2006
Date of Decision 28-Sep-2007
Date of Acceptance 13-Apr-2008

Correspondence Address:
A A Shirwaikar
Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal-576 104
India
Login to access the Email id


DOI: 10.4103/0250-474X.41464

PMID: 20046721

Get Permissions

   Abstract  

A novel, simple, sensitive and rapid spectrophotometric method has been developed for simultaneous estimation of ambroxol hydrochloride and levocetirizine dihydrochloride. The method involved solving simultaneous equations based on measurement of absorbance at two wavelengths 242 nm and 231 nm, the g max of ambroxol hydrochloride and levocetirizine dihydrochloride, respectively. Beer's law was obeyed in the concentration range 10-50 μg/ml and 8-24 μg/ml for ambroxol hydrochloride and levocetirizine dihydrochloride respectively. Results of the method were validated statistically and by recovery studies.


Keywords: Ambroxol hydrochloride, levocetirizine dihydrochloride, l max, spectrophotometric method


How to cite this article:
Prabu S L, Shirwaikar A A, Shirwaikar A, Kumar C D, Kumar G A. Simultaneous UV spectrophotometric estimation of ambroxol hydrochloride and levocetirizine dihydrochloride. Indian J Pharm Sci 2008;70:236-8

How to cite this URL:
Prabu S L, Shirwaikar A A, Shirwaikar A, Kumar C D, Kumar G A. Simultaneous UV spectrophotometric estimation of ambroxol hydrochloride and levocetirizine dihydrochloride. Indian J Pharm Sci [serial online] 2008 [cited 2014 Mar 5];70:236-8. Available from: http://www.ijpsonline.com/text.asp?2008/70/2/236/41464


Ambroxol hydrochloride (AMB) is chemically, trans-4-((2-amino-3,5-dibromobenzyl) amino) cyclohexanol hydrochloride. Levocetirizine dihydrochloride (LEVC) is chemically, (RS)-2-{4-[(R)-p-chloro-α-phenylbenzyl]-1-piperazinyl} ethoxyacetic acid dihydrochloride[1] . AMB reduces bronchial hyper-reactivity and acts as a mucolytic and cough suppressant [1] . LEVC is usually used in allergic conditions including rhinitis [1] . Combination of AMB and LEVC is used for the treatment of bronchitis. These two drugs are not official in any pharmacopoeia; hence no official method is available for the simultaneous estimation of AMB and LEVC in formulations. Capillary electrophoresis [2],[3],[4] , spectrometry [5] , gas chromatography [6] ,[7] , LC with potentiometric detection [8] , MS detection [9] and UV detection [10],[11],[12],[13] methods have been reported for the estimation of AMB. However, no references have been found for simultaneous determination of AMB and LEVC in pharmaceutical formulations. A successful attempt has been made to estimate these two drugs simultaneously by spectrophotometric analysis.

A Shimadzu UV/Vis spectrophotometer, model-1601 (Japan) was employed with spectral bandwidth of 0.1 nm and a wavelength accuracy of ±0.5 nm with automatic wavelength correction with a pair of 3 mm quartz cells. AMB and LEVC (Aristo Pharma Ltd.), methanol (Merck India Ltd., Mumbai) and distilled water were used in the present study.

Stock solutions (500 mg/ml) of AMB and LEVC were prepared by dissolving separately in 20 ml of water in a 100 ml clean volumetric flask, and the volume was made up to 100 ml with distilled water. The maximum absorbance of AMB and LEVC was obtained at 244 nm ('λ2 ) and 231 nm ('λ1 ), respectively. AMB and LEVC showed linearity with absorbance in the range of 10-50 mg/ml and 8-24 mg/ml at their respective maxima, which were validated by least square method. Coefficients of correlation were found to be 0.9992 for AMB and 0.9993 for LEVC. For simultaneous estimation of AMB and LEVC, a series of standard solutions in concentration range of 2 to 24 mg/ml, were prepared by diluting appropriate volumes of the standard stock solutions. The scanning of solutions of AMB and LEVC were carried out in the range of 200 to 400 nm against water as blank for obtaining the overlain spectra that are used in the analysis [Figure 1]. Absorbance and absorptivities of series of standard solutions were recorded at selected wavelengths λ1 and λ2 .

The absorptivity values for AMB and LEVC are shown in [Table 1]. The optical characteristics and regression values for the calibration curve are presented in [Table 2]. The method employed simultaneous equations using Cramer's rule and matrices (C 1 = 'λ2ε2×A 'λ1 - 'λ1ε2×A 'λ2 / 'λ1ε1× 'λ2ε2 - 'λ1ε2 x 'λ2ε1 and C 2 = 'λ1ε1×A 'λ2- 'λ2ε1×A 'λ1 / 'λ1ε1× 'λ2ε2- 'λ1ε2× 'λ2ε1 ). A set of two simultaneous equations were framed using the mean of absorptivity values, given as A 'λ1 = 211 C 1 +312 C 2 and A 'λ2 = 263 C 1 +71 C 2 , where, C 1 and C 2 are the concentrations of AMB and LEVC, respectively in simple solution (mg/ml). A 'λ1 and A 'λ2 are the absorbance of the sample solution measured at 231 and 244 nm, respectively.

Twenty tablets were weighed accurately. The average weight was determined and then ground to a fine powder. A quantity equivalent to 75 mg of AMB and 5 mg of LEVC were transferred to a 100 ml volumetric flask. The contents were sonicated for 10 min with 50 ml of distilled water and the volume was made up with distilled water. The solution was then filtered through a Whatman filter paper No. 40. The solution was further diluted with distilled water, to give concentrations of 30 and 2 mg/ml of AMB and LEVC, respectively. The absorbance of the resulting solution was measured at 231 and 244 nm.

To study accuracy, reproducibility, and precision of the proposed methods, recovery studies were carried out at three different levels by addition of standard drug solution to preanalysed samples. Results of recovery studies were found to be satisfactory which are presented in [Table 3].

The proposed method for simultaneous estimation of AMB and LEVC in combined sample solutions was found to be simple, accurate and reproducible. Beer's law was obeyed in the concentration range of 10-50 mg/ml and 8-24 mg/ml for AMB and LEVC, respectively. Co-efficient of variation was found to be 0.9992 and 0.9993 for AMB and LEVC, respectively. The percentage recovery studies were found to be in the range of 99.13 to 99.52% and 98.88 to 99.42% for AMB and LEVC, respectively. Once the equations are determined, analysis requires only the measuring of the absorbance of the sample solution at two wavelengths selected, followed by a few simple calculations. It is a method that can be employed for routine analysis in quality control laboratories.

 
   References   Top

1. Sweetman SC. Martindale, The Extra Pharmacopoeia, 34th ed. London: Pharmaceutical Press; 2004. p. 1114.   Back to cited text no. 1    
2. Pospisilova M, Polasek M, Jokl V. Determination of ambroxol or bromhexine in pharmaceuticals by capillary isotachophoresis. J Pharm Biomed Anal 1997;24:421-8.  Back to cited text no. 2    
3. Perez-Ruiz T, Martinez-Lozano C, Sanz A, Bravo E. Sensitive method for the determination of ambroxol in body fluids by capillary electrophoresis and fluorescence detection. J Chromatogr B 2000;742:205-10.  Back to cited text no. 3    
4. Perez-Ruiz T, Martinez-Lozano C, Sanz A, Bravo E. Determination of bromhexine and ambroxol in pharmaceutical dosage forms, urine and blood serum. J Chromatogr B 1997;692:199-205.  Back to cited text no. 4    
5. Dincer Z, Basan H, Goger NG. Quantitative determination of ambroxol in tablets by derivative UV spectrophotometric method and HPLC. J Pharm Biomed Anal 2003;31:867-72.  Back to cited text no. 5    
6. Colombo L, Marcucci F, Marini GM, Poerfederici P, Mussini E. Determination of ambroxol in biological material by gas chromatography with electron-capture detection. J Chromatogr 1990;530:141-7.  Back to cited text no. 6    
7. Schmid J. Assay of ambroxol in biological fluids by capillary gas-liquid chromatography. J Chromatogr 1987;414:65-75.  Back to cited text no. 7  [PUBMED]  
8. Bazylak G, Nagels LJ. Simultaneous high-throughput determination of clenbuterol, ambroxol and bromhexine in pharmaceutical formulations by HPLC with potentiometric detection. J Pharm Biomed Anal 2003;32:887-903.  Back to cited text no. 8  [PUBMED]  [FULLTEXT]
9. Kim H, Yoo JY, Han SB, Lee HJ, Lee KR. Determination of ambroxol in human plasma using LC-MS/MS. J Pharm Biomed Anal 2003;32:209-16.  Back to cited text no. 9  [PUBMED]  [FULLTEXT]
10. Heinanen M, Barbas C. Validation of an HPLC method for the quantification of ambroxol hydrochloride and benzoic acid in a syrup as pharmaceutical form stress test for stability evaluation. J Pharm Biomed Anal 2001;24:1005-10.  Back to cited text no. 10    
11. Koundorellis JE, Malliou ET, Broussali TA. High performance liquid chromatographic determination of ambroxol in the presence of different preservatives in pharmaceutical formulations. J Pharm Biomed Anal 2000;23:469-75.  Back to cited text no. 11    
12. Nobilis M, Pastera J, Svoboda D, Kvetina J, Acek K. High-performance liquid chromatographic determination of ambroxol in human plasma. J Chromatogr 1992;581:251-5.  Back to cited text no. 12    
13. Brizzi V, Pasetti U. High-performance liquid chromatographic determination of ambroxol in pharmaceuticals. J Pharm Biomed Anal 1990;8:107-9.  Back to cited text no. 13  [PUBMED]  [FULLTEXT]


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]

This article has been cited by
1 Development and Validation of First-Order Derivative Spectrophotometry for Simultaneous Determination of Levocetirizine Dihydrochloride and Phenylephrine Hydrochloride in Pharmaceutical Dosage Form
Kaminee Parmar,Sunil Baldania,Dimal Shah,Usmangani Chhalotiya,Naimin Parmar
International Journal of Spectroscopy. 2013; 2013: 1
[Pubmed]
2 Iodometric determination of milligram and microgram amounts of levocetirizine in pharmaceuticals
M. S. Raghu,K. Basavaiah,K. N. Prashanth,K. B. Vinay
Moscow University Chemistry Bulletin. 2013; 68(1): 67
[Pubmed]
3 DEVELOPMENT AND VALIDATION OF A NOVEL RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF SALBUTAMOL SULFATE, GUAIFENESIN, AND AMBROXOL HYDROCHLORIDE IN TABLET FORMULATION
Mukesh Maithani, Sandeep Sahu, Amrendra K. Chaudhary, Ranjit Singh
Journal of Liquid Chromatography & Related Technologies. 2012; 35(9): 1156
[VIEW]
4 Optimized and validated spectrophotometric methods for the determination of levocetirizine in pharmaceuticals based on charge transfer reaction
Madihalli Srinivas Raghu,Kanakapura Basavaiah
Journal of the Association of Arab Universities for Basic and Applied Sciences. 2012; 12(1): 33
[Pubmed]
5 Determination of montelukast sodium and levocetirizine dihydrochloride in combined tablet dosage form by hptlc and first-derivative spectrophotometry
Rote, A.R., Niphade, V.S.
Journal of Liquid Chromatography and Related Technologies. 2011; 34(3): 155-167
[Pubmed]
6 HPLC AND LC-MS STUDIES ON STRESS DEGRADATION BEHAVIOR OF LEVOCETIRIZINE AND DEVELOPMENT OF A VALIDATED SPECIFIC STABILITY-INDICATING METHOD
Rahul P. Gunjal, G. Raju, A. Ramesh Babu, N. Mallikarjun, Nalini Shastri, R. Srinivas
Journal of Liquid Chromatography & Related Technologies. 2011; 34(12): 955
[VIEW]
7 Simultaneous determination of chlorpheniramine maleate, guaiphenesin, terbutaline sulphate and ambroxol hydrochloride in pharmaceutical dosage form by UPLC
Bhavsar, H., Rohini, N., Raman, B.
Indian Drugs. 2011; 48(4): 42-48
[Pubmed]
8 A stability-indicating LC method for the simultaneous Determination of Levocetirizine dihydrochloride and Pseudoephedrine sulfate in Tablet dosage forms
Shaikh, K.A., Patil, A.T.
International Journal of ChemTech Research. 2010; 2(1): 454-461
[Pubmed]
9 Determination of montelukast sodium and levocetirizine dihydrochloride in combined pharmaceutical dosage Form by RP-HPLC
Rote, A.R., Niphade, V.S.
Latin American Journal of Pharmacy. 2010; 29(6): 1020-1023
[Pubmed]



 

Top
Print this article  Email this article
 
  Search
   
   Next article
   Previous article 
   Table of Contents
  
    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
    Article in PDF (181 KB)
    Citation Manager
    Access Statistics
    Reader Comments
    Email Alert *
    Add to My List *
* Registration required (free)  


    Abstract
    References
    Article Figures
    Article Tables

 Article Access Statistics
    Viewed 5659    
    Printed 78    
    Emailed 11    
    PDF Downloaded 772    
    Comments  [Add]    
    Cited by others  9    

Recommend this journal