A method for determining acid residues in remifentanil hydrochloride raw materials by high performance liquid chromatography

Abstract

The invention provides a method for measuring acid residues in remifentanil hydrochloride raw materials by high performance liquid chromatography, prepares acetic acid, propionic acid, and acrylic acid reference substance solutions, and places them in containers separately or together; take the test solution and inject it into the high-efficiency Liquid chromatograph, compare the peak time and peak shape in the chromatogram of the test product with the peak time and peak shape of acetic acid, propionic acid, and acrylic acid in the chromatogram of the reference solution, and determine whether the test solution contains acetic acid, For propionic acid and acrylic acid, the peak area value was substituted into the linear equation to calculate the acid content in remifentanil hydrochloride. This method finds the maximum absorption of the three by screening the wavelength, and uses the acetonitrile / water binary mobile phase to adjust the pH value or the two-phase ratio, and select the appropriate pH value and two-phase ratio to regulate acetic acid, propionic acid, The retention time of acrylic acid on the chromatographic column improves the resolution and number of theoretical plates of acetic acid, propionic acid and acrylic acid, improves the chromatographic peak shape, and the blank solvent does not interfere with the detection of the three.

Description

A method for the determination of acid residues in remifentanil hydrochloride raw materials by high performance liquid chromatography method technical field The present invention relates to a kind of method for measuring acid residue in remifentanil hydrochloride, be specially adopting high performance liquid chromatography A method for the detection of acetic acid, propionic acid and acrylic acid residues in remifentanil hydrochloride. Background technique Remifentanil hydrochloride (Remifentanil Hydrochloride), chemical name is 4-(methoxycarbonyl)-4- [(1-oxypropyl)anilino]-1-piperidine propionate methyl ester hydrochloride is a novel opioid analgesic with No accumulation, stable blood drug concentration, short duration of action, strong analgesic titer, rapid recovery of patients after medication, mild adverse reactions, etc. point. Clinically, it is mainly used for induction of general anesthesia and maintenance of analgesia during general anesthesia. Structu...

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Problems solved by technology

In the 2015 edition of China Pharmacopoeia General Rule 0861 Determination of Residual Solvents, Attachment 1 limits the content of acetic acid solvent residues, but does not limit the content of propionic acid and acrylic acid, and there is no corresponding determination method guidance, although these three The content of acid is very small, but the control of its residue is very important to improve product quality and is an important factor affecting product quality

And in the prior art, there is no record of the determination method of the above three acid residues in remifentanil hydrochloride products

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