Method for simultaneously separating and quantifying multiple components

Abstract

The invention provides a method for simultaneously separating and quantifying multiple components. The method comprises the steps of sample pretreatment and sample detection. The method provided by the invention has good specificity, and can avoid the interference of various components, especially components (such as polyethylene glycol and povidone) which are easy to interfere with each other, inmeasurement. The invention provides a good method for reverse engineering, component analysis, release detection of auxiliary materials and the like of pharmaceutical preparations and other products(such as cosmetics and foods). The method is simple to operate, good in specificity and accuracy, wide in linear range and high in sensitivity, and the detection capability and the detection efficiency are greatly improved.

Description

technical field [0001] The invention belongs to the technical field of analysis, and mainly relates to a method for simultaneously separating and quantifying multiple components, more specifically, to a method for simultaneously separating and quantifying acrylic resin, povidone and polyethylene glycol in multiple components Methods. Background technique [0002] Acrylic resin (Polymethacrylates), the trade name is Eudragit, which includes methacrylic acid copolymer and methacrylate copolymer. Eudragit is widely used in gastric coating, enteric coating, sustained and controlled release coating, protective isolation coating, sustained release matrix material and matrix adhesive material of transdermal drug preparations. It has been more than half a century since the first product came out. It has been widely used in various pharmaceutical preparations and has become an important auxiliary material for many international famous brand preparations. At present, the detection m...

AI Technical Summary

Problems solved by technology

The reported detection methods for acrylic resin, povidone, and polyethylene glycol (gel permeation chromatography, titration, nitrogen determination, reversed-phase silica gel or hydrophobic interaction chromatography, spectrophotometry, etc.) have poor specificity, Other components are easy to interfere with the determination, and multiple components cannot be separated and quantified at the same time

① Determination of acrylic resin content: using the principle of acid-base titration, many acidic components are likely to interfere with the determination of the method; using the reported liquid phase gel chromatography, components such as polyethylene glycol are likely to interfere with the determination of acrylic resin, and Simultaneous separation and quantification of multiple components cannot be achieved

② Determination of povidone content: when using the nitrogen determination method to detect the content of povidone, many components in the sample contain nitrogen elements, which are prone to interference; the reversed-phase silica gel C18 reported in the literature is used as the high performance liquid chromatography of the stationary phase When the ultraviolet detector is used for detection, only the content determination of povidone can be realized, and the simultaneous separation and quantitative detection of multiple components cannot be realized.

③ Determination of polyethylene glycol content: using the reported liquid phase gel chromatography, povidone and other components are easy to overlap with polyethylene glycol chromatographic peaks, and cannot be separated and quantified; use hydrophobic interaction chromatography or use reversed-phase silica gel High performance liquid chromatography with C18, C8, and C4 as the stationary phase, because many components in the sample are strong polar compounds, all of which peak before and after the solvent peak, it is difficult to separate multiple components at the same time; using spectrophotometry , cumbersome operation (requires derivatization), susceptible to interference from other components, poor specificity and narrow linear range, unable to achieve simultaneous separation and quantification of multiple components

[0006] Simultaneously, in the existing gel permeation chromatography, when detecting the molecular weight of components such as acrylic resins, if the mobile phase uses strong polar reagents such as N,N-dimethylformamide as the mobile phase, in order to eliminate the bonding effect, it tends to Add lithium bromide, lithium chloride and other salts to strong polar reagents, lithium bromide, lithium chloride and other salts will cause great damage to the chromatographic column

[0007] Aiming at the problem that the above-mentioned detection method has poor specificity and cannot detect multiple components at the same time, the present invention provides a method for simultaneously separating and quantifying multiple components

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