Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Analysis of Related Compounds from Commercial Atenolol Raw Materials and Preparations by High-Performance Liquid Chromatography

HPLC를 이용한 시판 아테놀롤 원료 및 제품 중 유연물질의 분석

  • Published : 2004.12.20
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Abstract

Atenolol and related compounds found in raw materials and commercial products were analyzed by reversed-phase high-performance liquid chromatography. A mixed solution of phosphate buffer (3.4 g/l, pH 3.0), tetrahydrofurane and methanol (800:20:180, v/v/v) including sodium octanesulfonate (1 g/l) and tetrabutylammonium-hydrogensulfate (0.4 g/l) was used as mobile phase at the flow rate of 0.25 ml/min. Detection was carried out at UV 226 nm. Atenolol related compounds, such as bis ether, tertiary amine and blocker acid were identified by comparing the retention time of the standard. The within-day and between-day precisions of the separated compounds were less than 1.2% and 3.4%, respectively. The contents of related compounds of the tested samples were under the limit prescribed in the European Pharmacopoeia. The pattern of the related compounds showed that atenolol raw materials and products could be classified in three different groups, indicating that the materials originated from different source or treated in different way.

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References

  1. 대한양전, 제8개정 (2002)
  2. 日本藥局方, 第十四改定 (2002)
  3. The United State Pharmacopoeia, 26th Ed. (2003)
  4. European Pharmacopoeia 4th Ed. (2002)
  5. British Pharmacopoeia (2002)
  6. The European Agency for the Evaluation of Medicinal Products, ICH TOPIC Q3A(R) Impurities testing guideline: Impurities in new drug substances. London (2002)
  7. U.S. Department of Health and Human Services, Guidance for industry Q3B(R) Impurities in new drug products. (2003)
  8. The European Agency for the Evaluation of Medicinal Products, ICH TOPIC Q3C(M) Maintenance of note for guidance on impurities: Residual solvents. London (2002)
  9. International Conference on Harmonisation, Q6A Test procedures and acceptance criteria for new drug substances and new drug products: Chemical substances. (1999)
  10. 식품의약품안전청 고시 제 2001-9호, 의약품등기준및시험방법심사의뢰서심사규정 제3조 (2001)
  11. 대한약학정보화재단, Drug Information in Korea, pp. 60-62 (2002)
  12. E.M. Sheldon, Development of a LC-LC-MS complete heartcut approach for the characterization of pharmaceutical compounds using standard instrumentation, J Pharm. Biomed. Anal., 31, 1153-1166 (2003) https://doi.org/10.1016/S0731-7085(03)00017-7
  13. A.M. Wolters, D.A. Jayawickrama, C.K. Larive and IV Sweedler, Capillary isotachophoresislNMR: extension to trace impurity analysis and improved instrumental coupling, Anal. Chem., 74, 2306-2313 (2002) https://doi.org/10.1021/ac015744p
  14. K.D. Altria, Application of microemulsion electrokinetic chromatography to the analysis of a wide range of pharmaceuticals and excipients, J Chromatogr. A, 844, 371-386 (1999)
  15. A. Shafaati and BJ. Clark, Development and validation of a capillary zone electrophoretic method for the determination. of atenolol in presence of its related substances in bulk and tablet dosage form, J. Pharm. Biamed. Anal., 14, 1547-1554 (1996) https://doi.org/10.1016/0731-7085(96)01772-4
  16. A. Shafaati and B.J. Clark, Development of a capillary zone electrophoresis method for atenolol and its related impurities in a tablet preparation, Anal. Proc., 30, 481-483 (1993)
  17. Z. Pawlak and BJ. Clark, The assay and resolution of the betablocker atenolol from its related impurities in a tablet pharmaceutical dosage form, J. Pharm. Biomed. Anal., 10, 329-334 (1992) https://doi.org/10.1016/0731-7085(92)80048-R