Simultaneous determination of 4-(oxiran-2-ylmethoxy)-9H-carbazol and 2-(2-methoxyphenoxy)ethylamin in carvedilol tablets by HPLC
Vol. 129 No. 1C (2020), Original Article
Vol. 129 No. 1C (2020)

Simultaneous determination of 4-(oxiran-2-ylmethoxy)-9H-carbazol and 2-(2-methoxyphenoxy)ethylamin in carvedilol tablets by HPLC

Original Article
https://doi.org/10.26459/hueuni-jns.v129i1C.5809
Published 2020-06-30
Nguyen Huu Tien
University of Medicine and Pharmacy, Hue University, 6 Ngo Quyen St., Hue, Vietnam
Ho Ngoc Lan Anh
University of Medicine and Pharmacy, Hue University, 6 Ngo Quyen St., Hue, Vietnam
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1.
Tiến NH, Anh HNL. Simultaneous determination of 4-(oxiran-2-ylmethoxy)-9H-carbazol and 2-(2-methoxyphenoxy)ethylamin in carvedilol tablets by HPLC. hueuni-jns [Internet]. 2020Jun.30 [cited 2024Dec.27];129(1C):23-30. Available from: https://jos.hueuni.edu.vn/index.php/hujos-ns/article/view/5809
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Abstract

Carvedilol is widely used in the treatment of cardiovascular diseases such as hypertension, ischemia, or heart failure. US pharmacopoeia 41 limits the allowable levels of nine related compounds of carvedilol in tablets. Among them, compound D (4-(oxiran-2-ylmethoxy)-9H-carbazole) and E (2-(2-methoxy phenoxy)ethylamin) are the synthetic materials for carvedilol, which appear in raw material and tablets. This research aims to develop a simple method for the determination of these two compounds in the tablets by using high-performance liquid chromatography (HPLC). The HPLC conditions were optimized as follows: Zorbax Eclipse XDB-C8 column (150×4.6 mm, 5 µm); mobile phase: acetonitrile and phosphate buffer (pH 2 + 1-heptanesulfonic acid 1.5 mM) (50:50, v/v); wavelength: 220 nm for compound E and 240 nm for compound D. This method was validated according to The International Conference of Harmonization guideline, and it can be used for the simultaneous determination of compounds D and E in the tablets.

https://doi.org/10.26459/hueuni-jns.v129i1C.5809
PDF (Vietnamese)

References

  1. Kumar KS, Reddy KT, Omprakash G, Dubey PK. Synthesis and characterization of potential impurities in key intermediates of Carvedilol: A β-adrenergic receptor. Journal of Chemical and Pharmaceutical Research. 2011;3(6):33-45.
  2. Rao LSS, Madhavan P, Prakash KV. Development and validation of stability indicating method for the quantitative determination of carvedilol and its related impurities in pharmaceutical dosage forms using RP HPLC. Journal of Chemical and Pharmaceutical Research. 2015;7(9):144-154.
  3. Ciobanu A-M, Pop AL, Crişan S, Pali M, Burcea-Dragomiroiu GTA, Popa DE, et al. HPLC studies for assessing the stability of carvedilol tablets. Farmacia. 2017;65(4):523-531.
  4. LGC Mikromol. Certificate of Analysis Reference Material: 4-(2,3-Epoxypropoxy)carbazole [internet]. Luckenwalde: LGC GmbH; Aug 2019. 8 p. Available from: https://assets.lgcstandards.com/sys-master%2Fpdfs%2Fh67%2Fhac%2F10133340356638%2FCOA_MM0291.10-0025_ST-WB-CERT-2967234-1-1-1.PDF?_ga=2.250148678.1155308396.1602519630-1809591917.1602519630
  5. LGC Mikromol. Certificate of Analysis Reference Material: : 2-(2-Methoxyphenoxy)ethylamine Hydrochloride [internet]. Luckenwalde: LGC GmbH; Dec 2019. 9 p. Available from: https://assets.lgcstandards.com/sys-master%2Fpdfs%2Fh9a%2Fh0f%2F10136119672862%2FCOA_MM0291.11_ST-WB-CERT-3019428-1-1-1.PDF?_ga=2.216773718.1155308396.1602519630-1809591917.1602519630
  6. The United States pharmacopeia 41. National formulary 36. Vol. 1. Rockville (MD): United States Pharmacopeial Convention; 2018. Carvedilol, Carvedilol Tablets; p. 729-733.
  7. Kang T, Gu X, He J, Zheng G; Zheng J. Determination of impurities D and E of carvedilol tablets by RP-HPLC. Chinese Journal of Pharmaceutical Analysis. 2015; 35(10):1838-1842.
  8. British Pharmacopoeia. London (UK): The Stationery Office; 2018. Carvedilol Tablets.
  9. The European Medicines Agency (EMA). Validation of analytical prrocedures: definitions and methodology [internet]. London: EMEA, 1995. 15 p. Report no.: CPMP/ICH/381/95. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf
  10. Huber L. Validation and Qualification in Analytical Laboratories. 2nd ed. New York: Informa Healthcare USA; 2007. 288 p.
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