An ultra-high performance liquid chromatography detection method for terlipressin and its impurities

Abstract

The invention provides an ultra-high performance liquid chromatogram detection method for segregation analysis of terlipressin and impurities thereof. The method comprises the step of and carrying out gradient elution on the terlipressin and the impurities thereof by taking a mobile phase A and a mobile phase B which are prepared from a buffer solution and an organic solvent in different proportions as moving phases in an ultra-high performance liquid chromatograph, thereby realizing rapid segregation analysis of the terlipressin and the impurities thereof.

Description

technical field

[0001] The invention relates to a method for separating and analyzing terlipressin and its impurities by using ultra-high performance liquid chromatography. Background technique

[0002] The structure of Terlipressin is

[0003] Gly-Gly-Gly-c[Cys-Tyr-Phe-Gln-Asn-Cys]-Pro-Lys-Gly-NH 2 (SEQ ID NO: 1), it is a kind of artificially synthesized long-acting vasopressin preparation, as a kind of prodrug, it is inactive in itself, and it is detached by aminopeptidase in the body through the action of aminopeptidase. After a glycyl residue, the active lysine vasopressin is slowly "released", which can contract visceral vascular smooth muscle and reduce visceral blood flow (such as reducing blood flow in the mesentery, spleen, uterus, etc.), thereby It reduces portal blood flow and portal pressure, and also acts on smooth muscles such as the esophagus and uterus. On the other hand, terlipressin can also reduce plasma renin concentration, thereby reducing the product...

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