DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROSCOPIC METHOD FOR ESTIMATION OF CARBAMAZEPINE IN BULK AND TABLET DOSAGE FORM

  • Nityanand Zadbuke Department of Pharmaceutics, Yash Institute of Pharmacy, Aurangabad 431134, Maharashtra, India
  • Sadhana Shahi
  • Ajit Jadhav
  • Santosh Borde

Abstract

Objective: To develop and validate simple, accurate, rapid, precise, reproducible and cost effective spectrophotometric method for the quantitative estimation of carbamazepine in a pharmaceutical formulation.

Methods: The developed UV spectrophotometric method for the quantitative estimation of carbamazepine is based on measurement of absorption at maximum wavelength 284 nm using methanol as a solvent. The stock solution of carbamazepine was prepared, and subsequent suitable dilution was prepared in distilled water to obtained standard curve. The standard solution of carbamazepine shows absorption maxima at 284 nm.

Results: The drug obeyed beer lambert’s law in the concentration range of 2-14 µg/ml with regression 0.9997 at 284 nm. The overall % recovery was found to be 99.99% which reflects that the method was free from the interference of the impurities and other excipients used in the formulation. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for inter-day and intra-day precision was found to be 0.1568 and 0.1746 respectively which is<2% hence proved that method is precise.

Conclusion: The results of analysis have been validated as per International Conference on Harmonization (ICH) guidelines. The developed method can be adopted in routine analysis of carbamazepine in tablet dosage form as well bulk dosage form.

Keywords: Carbamazepine, UV Spectrophotometry, Method development, Validation, ICH guidelines, Methanol.

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References

1. Tripathi KD. Drugs for Central Nervous System, Essentials of Medical Pharmacology. New Delhi: Jaypee; 2013.
2. Brothers Medical Publishers Pvt. Ltd; 2003. p. 370-4.
3. David AW, Thomas LL. Foye’s principle of medicinal chemistry. 5th edition, Lippincott Williams and Wilkins; 2002. p. 384-92.
4. Lawrence B, John L. Goodman and Gilman’s, Pharmacotherapy of the epilepsies, the pharmacological basis of therapeutics. 9th edition. McGraw-Hill Health profession division; 1995. p. 473.
5. Rang HP, Dale MM, Ritter JM, Flower RJ, Henderson G. Rang and dale’s Pharmacology. 6th edition. Elsevier Churchill Livingstone, London; 2007. p. 579-84.
6. The United States Pharmacopoeia Drug Information, Maryland, The United States Pharmacopoeia; 2007. p. 65.
7. Indian Pharmacopoeia. Ministry of health and family welfare government of India. The Controller Publication. Vol. I. New Delhi; 2010. p. 977-8.
8. British Pharmacopoeia. British Pharmacopoeia commission laboratory. Vol. I. London; 2010. p. 367.
9. Borse MP, Mulgund SV. UV Spectrophotometric estimation of carbamazepine in bulk and tablet dosage form. Scholars Res Library Pharm Lett 2015;7:272-5.
10. Mowafy HA, Alanazi FK. Development and validation of an HPLC–UV method for the quantification of carbamazepine in rabbit plasma. Saudi Pharm J 2012;20:29-34.
11. Gupta AK, Patel PK. Analytical method validation of stability-indicating HPLC method for determination of assay of carbamazepine CR tablets. Global Res Anal 2013;2:8-9.
12. Datar PA. Quantitative bioanalytical and analytical method development of dibenzepne derivative; carbamazepine: a review. J Pharm Anal 2015;5:213-22.
13. Katariya VR, Karva GS, Shahi SR. Spectrophotometric estimation of Ritonavir. Inventi Rapid: Pharm Analysis and Quality Assurance; 2013.
14. Katariya VR, Karva GS, Katariya MV, Shahi SR. Spectrophotometric Estimation of Efavirenz. Inventi Rapid: Pharm Analysis and Quality Assurance; 2013.
15. Parkh DR, Patil MP, Sonawane SS, Jain CP. Development and validation of spectrophotometric method for estimation of mebendazole in bulk and pharmaceutical formulation. World J Pharm Res 2015;4:2223-35.
16. International Conference on Harmonization (ICH), Q2A. Validation of Analytical Procedures: Methodology. Geneva; 1994.
17. The United State Pharmacopoeia (USP30-NF25). Validation of Compendial Procedures. National Publishing, Philadelphia, Asian edition; 2007. p. 1225.
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How to Cite
Zadbuke, N., S. Shahi, A. Jadhav, and S. Borde. “DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROSCOPIC METHOD FOR ESTIMATION OF CARBAMAZEPINE IN BULK AND TABLET DOSAGE FORM”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 8, no. 2, Feb. 2016, pp. 234-8, https://innovareacademics.in/journals/index.php/ijpps/article/view/9791.
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