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Method for Determination of Dissolution Rate of 5 Components in Compound Reserpine Tablets by Ultra High Performance Liquid Chromatography

A technology of compound reserpine and ultra-high performance liquid phase, which is applied in the direction of measuring devices, material separation, and analysis of materials, can solve the problems of large sample volume and long running time of samples in pharmacopoeia methods, and achieve high sensitivity, good selectivity, The effect of the separation effect is obvious

Active Publication Date: 2019-03-22
CHANGZHOU PHARMA FACTORY
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

And using the UPLC method to simultaneously determine five components in compound reserpine tablets: hydrochlorothiazide, dihydralazine sulfate, promethazine hydrochloride, vitamin B1 and vitamin B6, which have not been reported yet
Due to the large sample size and the long running time of the pharmacopoeia method for the determination of the concentration trends of the five main components of Compound Reserpine Tablets during the dissolution process, a rapid dissolution method was developed to evaluate the quality of the drug. is of great significance

Method used

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  • Method for Determination of Dissolution Rate of 5 Components in Compound Reserpine Tablets by Ultra High Performance Liquid Chromatography
  • Method for Determination of Dissolution Rate of 5 Components in Compound Reserpine Tablets by Ultra High Performance Liquid Chromatography
  • Method for Determination of Dissolution Rate of 5 Components in Compound Reserpine Tablets by Ultra High Performance Liquid Chromatography

Examples

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Effect test

Embodiment 1

[0071] The method for measuring the dissolution rate of 5 components in compound reserpine tablets provided by the present embodiment with ultra-high performance liquid chromatography is as follows:

[0072] (1) Accurately weigh the appropriate amount of vitamin B1 reference substance, vitamin B6 reference substance, hydrochlorothiazide reference substance, promethazine hydrochloride reference substance, and dihydralazine sulfate reference substance, and finally add the corresponding dissolution medium to dilute to a concentration of vitamin B1 control substance 1 μg / mL of vitamin B6 reference substance, 1 μg / mL of vitamin B6 reference substance, 3.1 μg / mL of hydrochlorothiazide reference substance, 2.1 μg / mL of promethazine hydrochloride reference substance, and 4.2 μg / mL of dihydralazine sulfate reference substance, as a reference substance solution, detected by ultra-high performance liquid chromatography, the results are shown in Figure 20 , the results showed that the re...

Embodiment 2

[0094] The method for measuring the dissolution rate of five components in compound reserpine tablets by ultra-high performance liquid chromatography provided in this example is basically the same as that in Example 1, the difference is that the dissolution medium used in this example is pH4.5 Sodium acetate buffer solution.

[0095] see results image 3 and Figure 4 .

[0096] In the dissolution medium of the sodium acetate buffer solution of pH4.5, the peak shape of each active component (vitamin B1, vitamin B6, hydrochlorothiazide, dihydralazine sulfate, promethazine hydrochloride) is good ( Figure 4 ), can accurately quantitatively analyze, and after 45min, the dissolution rate of each active component is more than 85% ( image 3 ).

Embodiment 3

[0098] The method provided in this example to measure the dissolution rate of five components in compound reserpine tablets by ultra-high performance liquid chromatography is basically the same as that in Example 1. The difference is that the dissolution medium used in this example is pH 6.8. Sodium phosphate buffer solution.

[0099] see results Figure 5 and Figure 6 .

[0100]In the dissolution medium of the sodium phosphate buffer solution of pH6.8, the peak shape of each active component (vitamin B1, vitamin B6, hydrochlorothiazide, dihydralazine sulfate, promethazine hydrochloride) is good ( Figure 6 ), can accurately quantitatively analyze, and after 45min, the dissolution rate of each active component is more than 85% ( Figure 5 ).

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Abstract

The invention discloses a method for determining the dissolution rate of five components in compound reserpine tablets through ultra-performance liquid chromatography, and relates to the field of analytic chemistry. The method comprises the steps that gradient elution is performed on a mobile phase composed of a mobile phase A and a mobile phase B; the mobile phase A is a water solution containinghexanesulfonate, wherein the concentration of the hexanesulfonate is 0.05-0.1%, and pH is 2.5-3.0; the mobile phase B is a mixing solution of methyl alcohol and acetonitrile, and the volume ratio ofmethyl alcohol to acetonitrile is (4.5-5.5):1; peaks can be effectively separated out from the five components of vitamin B1, vitamin B6, hydrochlorothiazide, dihydralazine sulfate and promethazine hydrochloride in the compound reserpine tablets, the number of theoretical plates and the separation degree meet the requirements, the separation effect is obvious, and the dissolution rate of five components in compound reserpine tablets can be determined; the method has the advantages of being simple, rapid, high in sensitivity, good in selectivity and the like.

Description

technical field [0001] The invention relates to the field of analytical chemistry, in particular to a method for measuring the dissolution rates of five components in compound reserpine tablets by ultra-high performance liquid chromatography. Background technique [0002] Compound Reserpine Tablets is a multi-component, low-dose compound antihypertensive drug designed by Professor Kuang Ankun, former director of the Shanghai Institute of Hypertension. It is a milestone traditional fixed compound preparation in the history of hypertension prevention and treatment in my country. This product is recorded in the 2015 edition of the Chinese Pharmacopoeia and is suitable for early and middle-stage hypertension. [0003] Since the 2015 version of the Chinese Pharmacopoeia standard only records the dissolution of two components (hydrochlorothiazide and promethazine hydrochloride), the limit is not less than 70% in 45 minutes; the method is the paddle method, 50 rpm; the medium is 0....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 钱丽红臧红芬黄冰
Owner CHANGZHOU PHARMA FACTORY
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