• Archives of Pharmacal Research
• /
• v.29 no.4
• /
• pp.339-342
• /
• 2006

A simple high performance liquid chromatographic (HPLC) method was developed for the determination of tolperisone in human plasma. Tolperisone and internal standard (chlorphenesin) were isolated from 1 mL of plasma using 8 mL of dichlormethane. The organic phase was collected and evaporated under nitrogen gas. The residue was then reconstituted with 300 mL aliquot of mobile phase and a 100 mL aliquot was injected onto the $C_{18}$ reverse-phased column. The mobile phase, $45\%$ methanol containing $1\%$ glacial acetic acid and $0.05\%$ 1-hexanesulfonic acid was run at a flow rate of 1 mL/min. The column effluent was monitored using UV detector at 260 nm. The retention times for tolperisone and the internal standard were approximately 7.1 and 8.4 min, respectively. The standard curve was linear with minimal intra-day and inter-day variability. The quantification limit of tolperisone in human plasma was 10 ng/ mL. The proposed method has been applied to the determination of pharmacokinetic profile of tolperisone in Koreans. The T max of tolperisone in Koreans $(0.94{\pm}0.42\;h)$ was not significantly differ from that reported in Europeans (0.5-1 h), but the mean half-life in Koreans $(1.14{\pm}0.27\;h)$ was shorter than that in Europeans $(2.56{\pm}0.2\;h)$. The proposed HPLC method is simple, accurate, reproducible and suitable for pharmacokinetic study of tolperisone.

• Proceedings of the PSK Conference
• /
• 2002.10a
• /
• pp.241.1-241.1
• /
• 2002

Tolperisone hydrochloride is used as a muscle relaxant. Very few assay methods of tolperisone were reported. such as potentiometry. spectrophotometry and high performance thin layer chromatography. In addition. there is no report related to HPLC method to determine the tolperisone level in biological sample. In this study, A very sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method for the determination of tolperisone HCI in plasma has been developed. (omitted)

• Analytical Science and Technology
• /
• v.30 no.1
• /
• pp.32-38
• /
• 2017

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.

• Proceedings of the PSK Conference
• /
• 2003.04a
• /
• pp.304.1-304.1
• /
• 2003

We aimed at determining bioavailability of tolperisone, a muscle relaxant. and developing a simple analysis in human blood using HPLC. A rapid and snsitive HPLC method was developed and validated using reverse-phase C18 column with retention time and limit of quantification of toferisone being 7.3 min and 20 ng/$m\ell$, respectively. Quantification was performed at 260 nm with chlorphenesin as internal standard. (omitted)