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Development of high performance liquid chromatography assay method of tramadol hydrochloride injection

  • Kim, DongHyeon (College of Pharmacy, Kangwon National University) ;
  • Rhee, Hee Jae (College of Pharmacy, Kangwon National University) ;
  • Mai, Xuan-Lan (College of Pharmacy, Kangwon National University) ;
  • Kang, Jong-Seong (College of Pharmacy, Chungnam National University) ;
  • Woo, Mi Hee (College of Pharmacy, Catholic University of Daegu) ;
  • Na, Dong-Hee (College of Pharmacy, Chungang University) ;
  • Chun, In-Koo (The Society of Korean Official Compendium for Public Health) ;
  • Kim, Kyeong Ho (College of Pharmacy, Kangwon National University)
  • Received : 2018.04.19
  • Accepted : 2018.06.01
  • Published : 2018.06.25

Abstract

Currently, ultraviolet-visible spectrophotometry and titration methods are used for assay tests of tramadol hydrochloride injection and raw material in the Korean Pharmacopoeia XI (KP XI). Titration has also been used in the British Pharmacopoeia (BP 2013) for the assay test of tramadol hydrochloride, and the HPLC assay for tramadol hydrochloride raw material has been used in the United States Pharmacopeia (USP 39). In this study, we developed an alternative HPLC assay method for tramadol hydrochloride injection that is up to date and specific, and employs the same method as tramadol hydrochloride capsules. Validation of the HPLC method was conducted to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of the calibration curves in the desired concentration range was good ($r^2$ > 0.9999). RSDs of intra-day precision obtained were 0.05-0.08 % and inter-day precision obtained were 0.08-0.19 %. Accuracy was obtained with recoveries in the range of 98.16 % and 100.90 %. As a result of the system's suitability, the RSD of both retention time and the peak area obtained were 0.07 %. The values of the plate number and tailing factor of tramadol hydrochloride obtained were 7076 and 1.16, respectively. Because of the intermediate precision and robustness of the developed assay, it is expected to become a valuable tool for revising the Korean Pharmacopoeia (KP XI).

Keywords

References

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