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Determination of the quantity of tolperisone hydrochloride in tablets by high performance liquid chromatography

  • Truong, Quoc-Ky (College of Pharmacy, Kangwon National University) ;
  • Mai, Xuan-Lan (College of Pharmacy, Kangwon National University) ;
  • Kim, Dae Hyun (College of Pharmacy, Kangwon National University) ;
  • Kim, Jeon Kyung (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, Kyungpook National University) ;
  • Chun, In-Koo (The Society of Korean Official Compendium for Public Health) ;
  • Kim, Kyeong Ho (College of Pharmacy, Kangwon National University)
  • Received : 2016.10.17
  • Accepted : 2017.02.01
  • Published : 2017.02.25

Abstract

In attempt to contribute in official monographs of Korean Pharmacopoeia, an HPLC method was developed and fully validated for the determination of tolperisone hydrochloride in tablets which have never been published in other forgein Pharmacopoeia. Analysis was carried out in an ODS column ($250{\times}4.6mm$ I.D., $5{\mu}m$) with common solvents include acetonitrile and ammonium hydrophosphate buffer as mobile phase. The assay was validated according to International Conference on Harmonization (ICH) guidelines. The method has good linearity in the range of $5-200{\mu}g/mL$ tolperisone. Intra-day precision varied between 0.04 and 0.10 %. Relative standard deviations of inter-day precision ranged between 0.43 and 1.24 % for peak area. The percentage recovery of the tolperisone ranged between 99.8 and 101.2 % in material. Recoveries in tablets were ranged between 98.7 and 100.8 %, thus confirmed the suitability of method for estimation of tolperisone hydrochloride in tablet dosage form.

Keywords

tolperisone;HPLC;assay;validation;tablet dosage form

Acknowledgement

Supported by : Ministry of Food and Drug Safety

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