Development of the kinetic-spectrophotometric method for quantitative determination of zopiclone in tablets by the perhydrolysis reaction

Authors

  • M. Ye. Blazheyevskiy National University of Pharmacy, Ukraine
  • L. S. Kryskiw National University of Pharmacy, Ukraine

DOI:

https://doi.org/10.24959/nphj.14.1959

Keywords:

Zopiclone, perhydrolysis, kinetic spectrophotometric determination, 3, 3’, 5, 5’-tetramethylbenzidine

Abstract

A simple and express method for the quantitative determination of zopiclone in model solutions of the substance and in “Zopiclone” tablets, 7.5 mg, by the kinetic-spectrophotometric method according to 3,3’,5,5’-tetramethylbenzidine oxidation has been developed. It is based on the system of two coupled reaction: 4-methyl-1-piperazineperoxycarboxylic acid generated in zopiclone perhydrolysis reacts with the excess of hydrogen peroxide in the weak alkaline medium with formation of coloured 3,3’,5,5’-tetramethyldiphenylquinone diimine (λmax = 420 nm, рН = 8.4). The reaction is performed spectrophotometrically by measuring the rate of change of the absorbance at 420 nm. The method was used for constructing the calibration graph. The initial rate of the reaction was obtained from the linear site of the slope of the initial tangent to the absorbance-time curve. In the pH range of 8.2-8.5 the rate of the coloured product formation becomes maximum. The calibration graph for zopiclone has a linear dependence in the range of 6-36 mg/l with the limit of detection (LOD) and quantitation (LOQ) of 1.81 and 6.04 mg/l, respectively. For five determinations of 18, 24 and 30 mg/l of zopiclone RSD is 1.81, 1.46 and 1.69%, respectively. The analytical performance of the method was validated statistically with respect to LOD, LOQ, accuracy, precision and linearity for zopiclone estimation in a pure substance and the results were satisfactory. “Zopiclone” tablets compared to the reference method contain 99.83±1.19% of C17H17ClN6O3 (RSD = 0.96% , δ = -0.17%). The assay of zopiclone in the presence of its hydrolysis products without preliminary separation is an important advantage of the method.

References

Блажеєвський М.Є. // Збірник доповідей та повідомлень науково-практичної конференції «Стан і розвиток сухопутних військ на сучасному етапі. Проблеми розвитку та озброєння військової техніки». – Х.: ХІТВ НТУ «ХПІ», 2006. – С. 94-96.

Державна фармакопея України / Державне підприємство «Науково-експертний фармакопейний центр». – 1-е вид. – Доп. 2. – Х.: Державне підприємство «Науково-експертний фармакопейний центр», 2008. – 620 с.

Экспериандова Л.П., Беликов К.Н., Химченко С.В., Бланк Т.А. // ЖАХ. – 2010. – Т. 65, №3. – С. 229-234.

British Pharmacopoeia. – London: The Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency, 2009. – 10952 p.

Gebauer M., Alderman C. // Biomed. Chromatography. – 2002. – Vol. 16, №4. – P. 241-246.

Mistri H., Jangid A., Pudage A., Shrivastav P. // J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. – 2008. – Vol. 864, №1. – P. 137-148.

Nirogi R., Kandikere V., Mudigonda K. // Biomed. Chromatogr. – 2006. – Vol. 20, №8. – P. 794-799.

Rossi S., Anzillotti L., Castrignanò E., Frison G., Zancanaro F., Chiarotti M. // Drug Testing and Analysis. – 2014. – Vol. 6, №3. – P. 226-233.

Shu C., Zhang L., Dong Y., Wang S., Niu X., Liu J. // Chinese J. of Forensic Medicine. – 2013. – Vol. 28, №1. – P. 46-48.

Sweetman S (Ed), Martindale: The complete drug reference. London: Pharmac. Press. Electronic version, (Edition 2007)

Tonon M., Bonato P. // Electrophoresis. – 2012. – Vol. 33, №11. – P. 1606-1612.

Tonon M., Jabor V., Bonato P. // Anal. Bioanal. Chem. – 2011. – Vol. 400, №10. – P. 3517-3525.

Downloads

Published

2014-09-12

Issue

Section

Synthesis and Analysis of Biologically Active Substances