A Stability Indicating Method was Developed and Validation for the Estimation of Carbamazepine in Bulk and Tablet Dosage form by UV-Spectroscopic Techniques

  • Manmohan Ghosh Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA
  • Sumanta Mondal Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA
  • Subhadip Chakraborty Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA
  • Nikita Ghosh Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA

Abstract

Carbamazepine is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and nerve pain, such as trigeminal neuralgia and diabetic neuropathy. It is well known that contemporary pharmaceutical analysis establishes robust, sensitive, economic, stability-indicating analytical procedures. The current study aimed to develop and assess UV-spectrophotometric (zero order, first order, second order, area under the curve) methods for estimating carbamazepine in its pharmaceutical dosage form. Method A is a simple zero-order spectrophotometric method for determining carbamazepine at 285 nm, and the correlation coefficient in the linearity study was found to be 0.9976, LOD, and LOQ are 0.45 and 1.48 µg/ml. Method B is a first-order spectrophotometric method for determining carbamazepine at 269 nm, and the correlation coefficient in the linearity study was found to be 0.9944, LOD, and LOQ are 0.29 and 0.96 µg/ml. Method C is a second-order spectrophotometric method for determining carbamazepine at 254 nm, and the correlation coefficient in the linearity study was found to be 1.00, LOD, and LOQ are 0.62 and 2.04 µg/ml. Method D is an area under the curve spectrophotometric method for determining carbamazepine at 266 to 300 nm, and the correlation coefficient in the linearity study was found to be 0.9975, LOD, and LOQ are 0.14 and 0.46 µg/ml. All developed methods demonstrated good repeatability and recovery with %RSD < 2. Studies on stress degradation show that oxidation and acid degradation mostly impact carbamazepine solutions.


Keywords: Carbamazepine, UV-spectrophotometric, Tegrital, Degradation study.

Keywords: Carbamazepine, UV-spectrophotometric, Tegrital, Degradation study

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Author Biographies

Manmohan Ghosh, Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA

Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA

Sumanta Mondal, Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA

Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA

Subhadip Chakraborty, Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA

Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA

Nikita Ghosh, Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA

Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam-530 045, A.P., INDIA

References

1. Bertilsson L, Tomson T, "Clinical Pharmacokinetics and Pharmacological Effects Of Carbamazepine and Carbamazepine-10,11-Epoxide. An Update" Clin Pharmacokinet, 1986; 11(3):177-98. https://doi.org/10.2165/00003088-198611030-00001
2. Chen G, Pan B, Hawver DB, Wright CB, Potter WZ, Manji HK, "Attenuation of Cyclic AMP Production by Carbamazepine" J Neurochem, 1996; 67(5):2079-86. https://doi.org/10.1046/j.1471-4159.1996.67052079.x
3. Mattson RH, Cramer JA, Collins JF, Smith DB, Delgado-Escueta AV, Browne TR, Williamson PD, Treiman DM, McNamara JO, McCutchen CB, et al, "Comparison of Carbamazepine, Phenobarbital, Phenytoin, and Primidone in Partial and Secondarily Generalized Tonic-Clonic Seizures" N Engl J Med, 1985; 313(3):145-51. https://doi.org/10.1056/NEJM198507183130303
4. Tolou-Ghamari Z, Zare M, Habibabadi JM, Najafi MR, "A Quick Review of Carbamazepine Pharmacokinetics in Epilepsy from 1953 to 2012" J Res Med Sci, 2013;18(Suppl 1):S81-5.
5. Wiffen PJ, Derry S, Moore RA, McQuay HJ, "Carbamazepine for Acute and Chronic Pain in Adults" Cochrane Database Syst Rev, 2011; 19(1):CD005451. https://doi.org/10.1002/14651858.CD005451.pub2
6. Ambrósio AF, Soares-Da-Silva P, Carvalho CM, Carvalho AP, "Mechanisms of Action of Carbamazepine and its Derivatives, Oxcarbazepine, BIA 2-093, and BIA 2-024" Neurochem Res, 2002; 27(1-2):121-30.
7. Tassaneeyakul W, Tiamkao S, Jantararoungtong T, Chen P, Lin SY, Chen WH, et al, "Association between HLA-B*1502 and Carbamazepine-Induced Severe Cutaneous Adverse Drug Reactions in a Thai population" Epilepsia, 2010; 51(5):926-30. https://doi.org/10.1111/j.1528-1167.2010.02533.x
8. Pellock JM, "Carbamazepine Side Effects in Children and Adults" Epilepsia, 1987; 28(Suppl 3):S64-70. https://doi.org/10.1111/j.1528-1157.1987.tb05780.x
9. Mawazi SM, Hadi HAB, Al-Mahmood SMA, Doolaanea ABDA, "Development and Validation of UV-Vis Spectroscopic Method of Assay of Carbamazepine in Microparticles" Int J App Pharm, 2019; 11(1):34-37. https://doi.org/10.22159/ijap.2019v11i1.26256
10. Zadbuke N, Shahi S, Jadhav A, S Borde, "Development and Validation of UV-visible Spectroscopic Method for Estimation of Carbamazepine in Bulk and Tablet Dosage Form" Int J Pharm Pharm Sci, 2016; 8(2):234-238.
11. Padma A, Thejomoorthy K, Snehith B, Priyanka B, Kumar MP, "Estimation of Carbamazepine in Bulk and Pharmaceutical Dosage Form by Zero Order and Area Under the Curve UV Spectrophotometric Methods" International Journal of Scientific Engineering and Science, 2019; 3(3):8-11.
12. Borse MP, Mulgund SV, "UV Spectrophotometric Estimation of Carbamazepine in Bulk and Tablet Dosage Form" Der Pharmacia Lettre, 2015; 7 (5):272-275.
13. Mowafy HA, Alanazi FK, Maghraby EGM, "Development and Validation of an HPLC-UV Method for the Quantification of Carbamazepine in Rabbit Plasma" Saudi Pharm J, 2012; 20(1):29-34. https://doi.org/10.1016/j.jsps.2011.04.003
14. Sheikh RE, Gouda AA, Hassan WS, Hashem H, Ali M, Kandiel NF, "Development and Validation of a Rapid Stability Indicating HPLC Method for Determination of Carbamazepine in Pure and Dosage Forms" Chemical Science Transactions, 2016; 5(4):1026-1034.
15. Gupta AK, Patel PK, "Analytical Method Validation of Stability-Indicating HPLC Method for Determination of Assay of Carbamazepine CR Tablets" Global Journal For Research Analysis, 2013; 2(11):8-9.
16. United States pharmacopoeia. Vol. 42. US pharmacopoeia; 2019.p. NF-37.
17. Anonymous. Validation of analytical procedures: methodology. International Conference on Harmonization. Vol.Q2B; 2005.
18. Anonymous. Text on Validation of Analytical Procedures. International Conference on Harmonization (ICH). Vol. Q2. Geneva, Switzerland; 2005. (p. R1).
19. Mondal S, Reddy GS, Mondal P, Prathyusha VS, Nair AP, Rahaman ST, "Development and Validation of few UV Spectrophotometric Methods for the Determination of Valganciclovir in Bulk and Pharmaceutical Dosage Form" Pharm Methods, 2018; 9(2):64-68. https://doi.org/10.5530/phm.2018.2.12
20. Patra SR, Bali A, Saha M, "Derivative Spectrophotometric Methods for Determination of Gefitinib in Bulk and in Formulation" Journal of Applied Spectroscopy, 2021; 88(5):1088-1094. https://doi.org/10.1007/s10812-021-01284-3
21. Subhadip C, Nalanda BR, Pridhvi KG, Suraj M, Shyamdeo KT, "A New Second-Derivative Spectrophotometric Method for the Determination of Vildagliptin in Pharmaceutical Dosage Form" Int. J. Res. Pharm, Sci., 2021; 12(4):2610-2614. https://doi.org/10.26452/ijrps.v12i4.4914
22. Rathod RD, Rathod LD, Mundada AB, Patel HM, "Validated UV Spectrophotometric Methods for the Determination of Anticancer Drug Erlotinib Hydrochloride in Bulk and tablet formulations" Journal of Applied Spectroscopy, 2021; 88(4):882-886. https://doi.org/10.1007/s10812-021-01254-9
23. Chakraborty S, Mondal S, "A Green Eco-Friendly Analytical Method Development, Validation, and Stress Degradation Studies of Favipiravir in Bulk and Different Tablet Dosages Form by UV-spectrophotometric and RP-HPLC Methods with Their Comparison by Using ANOVA And In-Vitro Dissolution Studies" Int. J. Pharm. Investigation, 2023; 13(2):1-16. https://doi.org/10.5530/ijpi.13.2.039
24. ICH Q1A (R2) Stability Testing of New Drug Substances and Products: International Conference on Harmonization, IFPMA, Geneva, 2003.
25. ICH Q1A Stability testing: photostability testing new drug substances and products: International Conference on Harmonization, IFPMA, Geneva, 1996.
26. Mondal S, Narendra R, Ghosh D, Ganapaty S, "Development and Validation of RP-HPLC and UV Spectrophotometric Methods for the Quantification of Capecitabine" International Journal of Pharmacy and Pharmaceutical Sciences, 2016; 8(5):279-287
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Ghosh M, Mondal S, Chakraborty S, Ghosh N. A Stability Indicating Method was Developed and Validation for the Estimation of Carbamazepine in Bulk and Tablet Dosage form by UV-Spectroscopic Techniques. JDDT [Internet]. 15Mar.2023 [cited 14Apr.2024];13(3):85-04. Available from: https://jddtonline.info/index.php/jddt/article/view/5987