Validation methods quantifying zopiclone tablets by HPLC
Zopiclone is a nonbenzodiazepine hypnotic agent used in the treatment of insomnia. It is a cyclopyrrolone, which increases the normal transmission of the neurotransmitter GABA in the central nervous system, as benzodiazepines do, but in a different way. Due to adverse events (potentiation of other hypnotics, sedatives, anti-allergy, alcohol) Zopiclone used for non-medical purposes, and in overdose has toxicological significance. Based on the fact, that Zopiclone drugs have fairly high demand in the pharmaceutical market, there is no doubt in the supplying desirability of worthy quality control of these drugs.
Purpose of this paper is study and validation of requirements for Ukrainian pharmacopoeia to find convenient, economical, highly sensitive methods of quantitative determination of Zopiclone in dosage forms by high performance liquid chromatography.
Analytical equipment: chromatograph Thermo Spectra System 2000, electronic scales KERN ABT-120-5DM, measuring vessel class A.
Pharmaceutical preparations: tablets Zopiclone 7.5 mg (Ukraine) and tablets Sonnat-KMP 7.5 mg (Ukraine).
Spend chromatography following conditions: column – reversed phase Hypersil Gold C18, Thermo Scientific TM, 4 × 150 mm; particle size sorbent – 5 mm; mobile phase – a mixture of phosphate buffer:acetonitrile in the ratio of 80:20; the flow rate – 1 ml/min; detector – UV spectrophotometric wavelength 304 nm; semi-injector volume of samples is 20 ml.
The proposed method is applied to the two dosage forms of Zopiclone – tablets to 7.5 mg, produced by various Ukrainian pharmaceutical companies. The main characteristics was validated by Pharmacopoeia of Ukraine.
Thus, the developed method is simple and useful for routine analysis of zopiclone in pharmaceutical formulations and in-process quality control. According to the experimental data, the technique can be correctly reproduced and it is suitable for using in pharmaceutical and forensic analytical laboratories.
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