HPLC (High Performance Liquid Chromatography) method for determining dissolution rate of Lercanidipine hydrochloride tablet

A technology of lercanidipine hydrochloride and lerca hydrochloride, which can be used in measuring devices, instruments, scientific instruments, etc., and can solve the problems of excipients that interfere with specificity and lack of strength.

Inactive Publication Date: 2015-07-29
CHONGQING MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It may be due to the interference of excipients and the lack of specificity in the determination of the dissolution of lercanidipine hydrochloride tablets

Method used

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  • HPLC (High Performance Liquid Chromatography) method for determining dissolution rate of Lercanidipine hydrochloride tablet
  • HPLC (High Performance Liquid Chromatography) method for determining dissolution rate of Lercanidipine hydrochloride tablet
  • HPLC (High Performance Liquid Chromatography) method for determining dissolution rate of Lercanidipine hydrochloride tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] 1 Instruments and reagents

[0016] Waters 2695 high-performance liquid chromatograph; Swiss SOTAXAT7smart dissolution apparatus (Swiss SOTAX company), FODT-601 optical fiber drug dissolution real-time tester (Xinjiang Fukesi Analytical Instrument Co., Ltd.). Both lercanidipine hydrochloride tablets (10 mg / tablet specification, batch numbers 110901, 111001, 111002) and lercanidipine hydrochloride working reference substance (99.7% content) were provided by Chongqing Shenghuaxi Pharmaceutical Co., Ltd. Acetonitrile was chromatographically pure (Shandong Yuwang Industrial Corporation Chemical Plant), and other reagents were analytically pure.

[0017] 2 Methods and results

[0018] 2.1 Chromatographic conditions

[0019] The column is Waters SunFire C 18 (4.6mm×150mm, 5μm); the mobile phase is 0.15mol L -1 Sodium perchlorate solution (adjust the pH value to 3.0 with 70% perchloric acid)-acetonitrile (40:60); column temperature 25°C; detection wavelength 240nm; flow ra...

Embodiment 2

[0046] 2.1 Chromatographic conditions

[0047] The column is Waters SunFire C 18 (4.6mm×150mm, 5μm); the mobile phase is 0.15mol L -1 Sodium perchlorate solution (adjust the pH value to 4.0 with 70% perchloric acid)-acetonitrile (40:60); column temperature 25°C; detection wavelength 240nm; flow rate 1.0ml·min -1 ; The injection volume is 40 μL. The number of theoretical plates calculated based on the peak of lercanidipine hydrochloride is not less than 6000.

[0048] 4 Sample dissolution test

[0049] Get 6 tablets of this product, according to the dissolution test method (Chinese Pharmacopoeia 2010 edition two appendix XC dissolution test method), with 0.1mol L containing 0.3% (w / v) Tween 80 -1 500mL of hydrochloric acid solution is used as the dissolution medium, and the rotation speed is 50r·min -1 , operate according to the law, after 45 minutes, take the solution and filter it with a 0.45 μm microporous membrane as the test solution; take another appropriate amount o...

Embodiment 3

[0054] 2.1 Chromatographic conditions

[0055] The column is Waters SunFire C 18 (4.6mm×150mm, 5μm); the mobile phase is 0.15mol L -1 Sodium perchlorate solution (adjust the pH value to 3.0 with 70% perchloric acid)-acetonitrile (40:60); column temperature 30°C; detection wavelength 240nm; flow rate 1.0ml·min -1 ; The injection volume is 40 μL. The number of theoretical plates calculated based on the peak of lercanidipine hydrochloride is not less than 6000.

[0056] 4 Sample dissolution test

[0057] Get 6 tablets of this product, according to the dissolution test method (Chinese Pharmacopoeia 2010 edition two appendix XC dissolution test method), with 0.1mol L containing 0.3% (w / v) Tween 80 -1 500mL of hydrochloric acid solution is used as the dissolution medium, and the rotation speed is 50r·min -1 , operate according to the law, after 45 minutes, take the solution and filter it with a 0.45 μm microporous membrane as the test solution; take another appropriate amount o...

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Abstract

The invention relates to an HPLC (High Performance Liquid Chromatography) method for determining the dissolution rate of a Lercanidipine hydrochloride tablet. The method comprises the following steps: (1) test of the dissolution rate of the Lercanidipine hydrochloride tablet and preparation of a sample solution; (2) preparation of a reference solution of Lercanidipine hydrochloride; (3) HPLC determination, to be specific, performing determination analysis on the reference solution and the sample solution under the following chromatographic conditions: a chromatographic column is Waters SunFire C18 (4.6 mm*150 mm, 5 [mu]m), a flowing phase is formed by a 0.15 mol.L<-1> sodium perchlorate solution (of which the pH is adjusted by a 70% perchloric acid to be 3.0-4.0) and acetonitrile, the ratio of the sodium perchlorate solution to the acetonitrile is 40:60, the column temperature is 25-30 DEG C, the detection wavelength is 240 nm, the flow speed is 1.0 ml.min<-1>, and the sample injection amount is 40 [mu]L. A methodological test shows that the method is high in specificity, accurate in result, good in stability, simple and convenient to operate, and suitable for the determination of the dissolution rate of the Lercanidipine hydrochloride tablet, and can control the quality of the Lercanidipine hydrochloride tablet more scientifically and effectively.

Description

technical field [0001] The invention relates to a method for measuring the dissolution rate of chemical drug tablets, in particular to an HPLC method for determining the dissolution rate of lercanidipine hydrochloride tablets. Background technique [0002] Lercanidipine hydrochloride is a third-generation dihydropyridine calcium antagonist developed by the Italian company Recordati, which was first launched in the Netherlands in 1997. The structure of lercanidipine hydrochloride has added a diphenylalanyl group, so it has a strong lipophilicity, and its main function is to block the L-type calcium ion channel on the membrane of vascular smooth muscle cells, so as to reduce the calcium ions flowing into the cells, thereby relaxing vascular smooth muscle , expand blood vessels, lower blood pressure, and has the advantages of long-lasting drug effect, high blood vessel selectivity, and less adverse reactions. It is mainly used in the treatment of moderate and mild hypertension ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
Inventor 何丹杨林邱红梅张景勍
Owner CHONGQING MEDICAL UNIVERSITY
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