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KMID : 0385520170300010032
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Analytical Science & Technology
2017 Volume.30 No. 1 p.32 ~ p.38
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Determination of the quantity of tolperisone hydrochloride in tablets by high performance liquid chromatography
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Truong Quoc Ky
Mai Xuan Lan
Kim Dae-Hyun
Kim Jeon-Kyung
Kang Jong-Seong
Woo Mi-Hee
Na Dong-Hee
Chun In-Koo
Kim Kyeong-Ho
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Abstract
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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
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KEYWORD
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tolperisone, HPLC, assay, validation, tablet dosage form
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