Improved Spectrophotometric Pharmacopoeial Method for accurate Quantitation of Thiomersal content in Haemophilus influenzae type b (Hib)-TT Conjugate Vaccine

Authors

  • Neeraj Malik Scientist Grade II, National Institute of Biologicals (Ministry of Health and Family Welfare, Government of India) A-32, Sector-62, Noida-201 309
  • Harit Kasana Jr.Scientist, National Institute of Biologicals (Ministry of Health and Family Welfare, Government of India) A-32, Sector-62, Noida-201 309
  • Veenu Choudhary Bench Biologist, National Institute of Biologicals (Ministry of Health and Family Welfare, Government of India) A-32, Sector-62, Noida-201 309
  • Harsh Choudhary Bench Biologist, National Institute of Biologicals (Ministry of Health and Family Welfare, Government of India) A-32, Sector-62, Noida-201 309
  • Divya Srivastava Bench Biologist, National Institute of Biologicals (Ministry of Health and Family Welfare, Government of India) A-32, Sector-62, Noida-201 309
  • Vandana Tandasi Jr. Scientist, National Institute of Biologicals (Ministry of Health and Family Welfare, Government of India) A-32, Sector-62, Noida-201 309
  • Anu Prakash Bench Biologist, National Institute of Biologicals (Ministry of Health and Family Welfare, Government of India) A-32, Sector-62, Noida-201 309
  • G.R Soni Deputy Director (QC), National Institute of Biologicals (Ministry of Health and Family Welfare, Government of India) A-32, Sector-62, Noida-201 309
  • Surinder Singh Director, National Institute of Biologicals (Ministry of Health and Family Welfare, Government of India) A-32, Sector-62, Noida-201 309

DOI:

https://doi.org/10.7439/ijbar.v7i12.3689

Abstract

Vaccines remain one of the most effective ways to prevent infectious diseases globally. Accurate measurement of thiomersal content is an important parameter to ensure safety of vaccines though these vaccines are less in use. In the present study a simple, accurate and highly effective spectrophotometric improved method has been developed for determination of thiomersal in Hib-TT conjugate vaccine by using 0.01% and 0.005% concentration of dithizone for making stock and comparing these with 0.001% dithizone concentration mentioned in Indian Pharmacopoeia (2014). All the concentrations were evaluated at three different wavelength i.e. 538nm, 540 nm and 542nm. When all the three concentrations compared, the dithizone concentration 0.01 % has been found to be more accurate, linear and giving reproducible results. Among the three wavelengths, the best result has been obtained at wavelength 538nm. The improved method is accurate, specific, and easy to carry out, consumes little time and requires a few microliters of sample and therefore, improved method is recommended than the present pharmacopoeial method which underestimate the concentration of thiomersal and fails the otherwise passed Hib-TT conjugate vaccine.

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References

WHO Manual for the production and control of vaccines, Tetanus Toxoid, BLG/UNDP/77.2 Rev 1, 78-79, Appendix T.16

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Indian Pharmacopoeia (2014)

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Published

2016-12-30

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Section

Original Research Articles

How to Cite

1.
Improved Spectrophotometric Pharmacopoeial Method for accurate Quantitation of Thiomersal content in Haemophilus influenzae type b (Hib)-TT Conjugate Vaccine. Int J of Biomed & Adv Res [Internet]. 2016 Dec. 30 [cited 2024 Oct. 18];7(12):578-81. Available from: https://ssjournals.co.in/index.php/ijbar/article/view/3689