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Method for determining dissolution rate of rosuvastatin calcium preparation

A technology of rosuvastatin calcium and rosuvastatin, applied in the field of medicine, can solve the problems of inability to accurately reveal the dissolution rate, affecting the correctness of pharmaceutical preparations and the like

Inactive Publication Date: 2014-05-07
RUNZE PHARMACEUTICAL (SUZHOU) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Therefore, the current calculation method for the dissolution determination of rosuvastatin calcium preparations cannot accurately reveal its true dissolution rate, thereby affecting the correctness of the design of pharmaceutical preparations

Method used

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  • Method for determining dissolution rate of rosuvastatin calcium preparation
  • Method for determining dissolution rate of rosuvastatin calcium preparation
  • Method for determining dissolution rate of rosuvastatin calcium preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Chromatographic conditions: AgiLent Extend-C18 (4.6*250mm, 5μm); acetonitrile as mobile phase A, and 0.02% trifluoroacetic acid aqueous solution as mobile phase B, 0~13min, B: 63%, 13~27min, B: 63 %~10%; Detection wavelength: 242nm; Flow rate: 1.0mL / min; Column temperature: 40℃; Injection volume: 10μL.

[0092] Dissolution curve establishment in pH1.0 hydrochloric acid solution: get rosuvastatin calcium tablet (three batches), parallel 6 parts, according to dissolution assay method (Chinese Pharmacopoeia 2010 edition one appendix XC second method), with 900ml pH1.0 Hydrochloric acid solution is used as the dissolution medium, the rotation speed is 50rpm, operate according to the law, take 4ml samples at 5min, 10min, 15min, 30min, 45min, 60min, and 90min for analysis, filter, carry out alkali neutralization treatment on the subsequent filtrate, and adjust the pH value to 7.0 as The test solution.

[0093] The result is as figure 1 , that is, the chromatogram of the dis...

Embodiment 2

[0110] Chromatographic conditions: AgiLent Extend-C18 (4.6*250mm, 5μm); acetonitrile as mobile phase A, and 0.02% trifluoroacetic acid aqueous solution as mobile phase B, 0~13min, B: 63%, 13~27min, B: 63 %~10%; Detection wavelength: 242nm; Flow rate: 1.0mL / min; Column temperature: 40℃; Injection volume: 10μL.

[0111] Establishment of dissolution curve in acetic acid-ammonium acetate buffer solution (pH4.5): Take rosuvastatin calcium tablets (three batches), 6 copies in parallel, according to the dissolution method (Appendix XC second method of Chinese Pharmacopoeia 2010 edition) , take acetic acid-ammonium acetate buffer (pH4.5) as the dissolution medium 900ml as the dissolution medium, the rotation speed is 50rpm, operate according to the law, take 4ml samples at 5min, 10min, 15min, 30min, 45min, 60min for analysis, filter, and take the subsequent filtrate As the test solution.

[0112] The result is as Figure 4 , Dissolution chromatogram of rosuvastatin calcium tablets i...

Embodiment 3

[0116] Chromatographic conditions: AgiLent Extend-C18 (4.6*250mm, 5μm); acetonitrile as mobile phase A, and 0.02% trifluoroacetic acid aqueous solution as mobile phase B, 0~13min, B: 63%, 13~27min, B: 63 %~10%; Detection wavelength: 242nm; Flow rate: 1.0mL / min; Column temperature: 40℃; Injection volume: 10μL.

[0117] Dissolution curve establishment in 0.05M sodium citrate buffer solution (pH6.6): get rosuvastatin calcium tablet, parallel 6 parts, according to dissolution test method (Chinese Pharmacopoeia 2010 edition one appendix XC second method), with 900ml Phosphate buffer (pH 6.8) is used as the dissolution medium, and the rotating speed is 50rpm. Operate according to the law. Sampling 4ml at 5min, 10min, 15min, and 30min is analyzed, filtered, and the subsequent filtrate is taken as the test solution.

[0118] The result is as Figure 6 , that is, the dissolution chromatogram of rosuvastatin calcium tablets in 0.05M sodium citrate buffer (pH6.6).

[0119] Carry out di...

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Abstract

The invention relates to a method for determining dissolution rate of rosuvastatin calcium preparation. The method comprises the following steps: placing a rosuvastatin calcium preparation into a dissolution medium, then sampling and filtering the mixture, executing the alkaline neutralization pretreatment for the degraded sample, placing the neutralized sample by utilizing a liquid chromatograph, calculating a correction factor of the rosuvastatin degradation product relative to the rosuvastatin calcium, and calculating the accumulation dissolution percentage of rosuvastatin of the rosuvastatin calcium preparation in the dissolution medium according to the correction factor. By adopting the method, the weakness of the calculation deviation caused by the partial degradation of the rosuvastatin in the dissolution medium can be overcome, and the precise dissolution rate of the rosuvastatin calcium preparation in different sampling points can be accurately detected.

Description

technical field [0001] The invention relates to a rosuvastatin calcium preparation used for treating hyperlipidemia, in particular to a method for measuring the dissolution rate of the rosuvastatin calcium preparation, and belongs to the technical field of medicine. Background technique [0002] Most oral solid preparations must be absorbed into the blood circulation after administration, and can only be effective after reaching a certain blood concentration. The speed of drug absorption in the body is often determined by the speed of dissolution. Before being absorbed, the drug in the solid preparation must go through the process of disintegration and dissolution and then turn into a solution. Therefore, the accuracy of the dissolution test of pharmaceutical preparations directly affects the prediction of drug dissolution and in vivo absorption. [0003] Rosuvastatin Calcium is the second-generation statin powerful lipid-lowering drug, which is mainly used in the clinical ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 蔡垠苗艳武利周志亮朱金莲申晓凤
Owner RUNZE PHARMACEUTICAL (SUZHOU) CO LTD
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