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  • 한국과학기술정보연구원(KISTI) 서울분원 대회의실(별관 3층)
  • 2024년 07월 03일(수) 13:30
 

  • P-ISSN1225-0163
  • E-ISSN2288-8985
  • SCOPUS, ESCI, KCI

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  • P-ISSN 1225-0163
  • E-ISSN 2288-8985

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

분석과학 / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2017, v.30 no.1, pp.32-38
https://doi.org/10.5806/AST.2017.30.1.32
Quoc Ky Truong (강원대학교)
김경호 (강원대학교)
Xuan Lan Mai (강원대학교)
김대현 (강원대학교)
김전경 (강원대학교)
강종성 (충남대학교)
우미희 (대구가톨릭대학교)
나동희 (경북대학교)
전인구 (The Society of Korean Official Compendium for Publ)
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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 × 4.6 mm I.D., 5 μm) 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 μg/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


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