HPLC quantitative detection method of glycinamide hydrochloride in oxiracetam

Abstract

The invention provides an HPLC quantitative detection method of glycinamide hydrochloride in oxiracetam. The quantitative analysis is performed by using a reversed-phase high performance liquid chromatography peak external standard method. The chromatographic conditions are as follows: the chromatographic column is Welch Ultimate AQ-C18 with the area of 4.6 mm*250 mm and the length is 5 microns; the column temperature is 30 DEG C; the flow rate is 0.5 ml / min; the detection wavelength is 205nm; the feeding volume is 20 microlitres; the mobile phase is 0.05-mol / L monopotassium phosphate solution-0. 2-% sodium octane sulfonate. On the basis of the existing control method, the mobile phase system is changed and the ion pair reagent is added, so that the chromatographic peak of the glycinamidehydrochloride is well separated from the chromatographic peak of the oxiracetam without tailing; the quantitative accuracy is high; the separation method has high durability; and the control of oxiracetam product quality in the production process becomes convenient. The method has advantages of great easiness and high accuracy, precision, stability and reproducibility.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a detection method of glycinamide hydrochloride, a related substance of oxiracetam. Background technique [0002] Oxiracetam, its chemical name is 4-hydroxy-2-oxo-1-pyrrolidineacetamide, molecular formula: C 6 h 10 N 2 o 3 , molecular weight: 158.16. [0003] Its structural formula is: [0004] [0005] Oxiracetam is an analogue of piracetam, which can improve memory and learning functions in patients with Alzheimer's disease and memory impairment. Promote the synthesis of phosphorylcholine and phosphorylethanolamine, increase the ratio of ATP / ADP in the brain, and increase the synthesis of protein and nucleic acid in the brain. It is clinically used for the treatment of brain injury and the resulting neurological loss, memory and intellectual impairment. [0006] Combined with the oxiracetam process route, the impurity glycinamide hydrochloride is int...

AI Technical Summary

Problems solved by technology

[0012] (1) Through a comprehensive analysis of the impurity spectrum of oxiracetam, the chromatographic conditions of the pharmacopoeia standards for comments were used for the analysis of related substances. In the actual operation process, the above method is difficult to achieve the separation of oxiracetam and glycinamide hydrochloride , the separation effect is poor;

[0013] (2) The peak shape of glycinamide hydrochloride is poor and the tailing is serious, which leads to poor quantitative accuracy of glycinamide hydrochloride and makes the analysis results unreliable

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