UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF ACAMPROSATE CALCIUM IN TABLETS

Authors

  • T. RAJESH Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad, 501511, India.
  • A. Sowjanya Kumari Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal), Hyderabad, 501511, India.
  • S. Rakesh Reddy Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal), Hyderabad, 501511, India.
  • A. Ashok Kumar Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal), Hyderabad, 501511, India.

Keywords:

UV, Acamprosate calcium, Method development, Validation

Abstract

Objective: To develop a rapid UV spectrophotometric method for the quantitative estimation of Acamprosate calcium (333mg) in tablets and validate as per ICH guidelines.

Methods: The optimized method uses a diluent 100% Triethylammonium phosphate buffer (pH 4.0) for the estimation of assay of Acamprosate calcium at a detection wavelength of 208 nm.

Results: The developed method resulted in Acamprosate calcium exhibiting linearity in the range 30-90μg/ml. The precision is exemplified by relative standard deviation of 1.5%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) were found to be 99ng/ml, and 300ng/ml respectively.

Conclusion: A rapid UV spectrophotometric method was developed and validated for the quantitative estimation of Acamprosate calcium in tablets as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.

Downloads

Download data is not yet available.

Author Biography

T. RAJESH, Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad, 501511, India.

Department of Pharmaceutical Analysis and Quality assurance

References

Zornoza T, Cano MJ, Polache A, Granero L. Pharmacology of acamprosate:an overview. J CNS Drug Rev 2003;9(4):359-74.

Saivin S, Hulot T, Chabac S, Potgieter A, Durbin P, Houin G. Clinical pharmacokinetics of acamprosate. J Clin Pharmacokinet 1998;35(5):331-45.

Rhee YS, Park S, Lee TW, Park CW, Nam TY, Oh TO, et al. Investigation of the relationship between in vitro and in vivo release behaviors of acamprosate from enteric-coated tablets. J Arch Pharm Res 2008;31(6):798-804.

Espino D, Cruz MP. Acamprosate calcium (Campral®):An effective treatment for maintaining abstinence in alcohol-dependent patients in combination with psychosocial support. J Pharmacy Therapeutics 2005;30:497-505.

Lipha Pharmaceuticals Inc. Briefing Document for Acamprosate 333 mg Tablets. J Food and Drug Administration:Washington, DC, US;2002:1-311.

Blanchin MD, Baalbak B, Bosc N, Fabre H. Short-end injection technique in capillary electrophoresis for dissolution testing of tablets. J Anal Chim Acta 2000;415:67-73.

Fabre H, Perrin C, Bosc N. Determination of homotaurine as impurity in calcium acamprosate by capillary zone electrophoresis. J Chromatogr A 1999;853:421-430.

Chabenat C, Ladure P, Blanc-Continsouza D, Boismare F, Boucly P. Determination of calcium acetylhomotaurinate by liquid chromatography with fluorimetric and electrochemical detection. J Chromatogr B Biomed Sci Appl 1987;414:417-22.

Chabenat C, Ladure P, Moore N, Boucly P, Boismare F. Application of an analytical method to calcium acetylhomotaurinate determination in urine. J Arzneimittelforschung 1989;39:1413-4.

Girault J, Gobin P, Fourtillan JB. Determination of calcium acetylhomotaurinate in human plasma and urine by combined gas chromatography-negative-ion chemical ionization mass spectrometry. J Chromatogr 1990, 530:295-305.

Rhee YS, Park JH, Park S, Park CW, Ha JM, Jeong KW, Lee DS, Park ES. Analysis of Acamprosate in Beagle Dog Plasma by LC-MS-MS. J Arch Pharm Res 2008;31:1035-39.

Xu F, Quing Y, Shang B, Liang M, Zou Y, Xu G. Pharmacokinetics of Acamprosate Calcium in Healthy Chinese Subjects after Oral Administration of Three Dosage Levels. J Arzneimittelforschung 2009;59:631-4.

Ghosh C, Jha V, Shinde CP, Chakraborty BS. A LC-MS analysis of acamprosate from human plasma:pharmacokinetic application. J Drug Test Anal 2011;3(10):735-42.

Hammarberg A, Beck O, Eksborg S, Jayaram-Lindström N, Lindefeldt A, Andersson M, Brundin L, Reid MS, Franck J. Acamprosate determinations in plasma and cerebrospinal fluid after multiple dosing measured by liquid chromatography-mass spectroscopy:a pharmacokinetic study in healthy volunteers. J Ther Drug Monit 2010;32(4):489-96.

Rhee YS, Park JH, Park S, Park CW, Ha JM, Jeong KW, et al. Analysis of acamprosate in beagle dog plasma by LC-MS-MS. J Arch Pharm Res 2008;31(8):1035-9.

Kanchana Mala K, Babu Rao C, Nagiat TH, Mukkanti K, Prakash K, Challa BR. Quantification of Acamprosate in human plasma by LC-ESIMS/ MS with solid phase extraction:Application to a bioequivalence study. J Pharm Res 2013;7:389-96.

Kirankumar A, Mamatha B, Sasikala M, Monika S, Ranganayakulu D. UV spectrophotometric method development and stability studies of acamprosate calcium in bulk and tablet dosage form. Int J of Pharm Tech Res 2013;5(3):1241-6.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of Analytical Procedures. J Text and Methodology ICH Q2 (R1) 2005.

Published

31-08-2014

How to Cite

RAJESH, T., A. S. Kumari, S. R. Reddy, and A. A. Kumar. “UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF ACAMPROSATE CALCIUM IN TABLETS”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 6, no. 8, Aug. 2014, pp. 363-6, https://journals.innovareacademics.in/index.php/ijpps/article/view/1504.

Issue

Section

Original Article(s)

Most read articles by the same author(s)

1 2 3 > >>