CN104807898A - HPLC (High Performance Liquid Chromatography) method for determining dissolution rate of Lercanidipine hydrochloride tablet - Google Patents
HPLC (High Performance Liquid Chromatography) method for determining dissolution rate of Lercanidipine hydrochloride tablet Download PDFInfo
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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
The present invention relates to a kind of assay method of chemicals Dissolution of Tablet, be specifically related to a kind of HPLC assay method of Lercanidipine hydrochloride sheet dissolution rate.
Background technology
Lercanidipine hydrochloride (Lercanidipine hydrochloride) is the third generation dihydropyridine type calcium antagonists of Italian Recordati company exploitation, within 1997, goes on the market first in Holland.Add two phenylpropyl alcohol aminoalkyls in Lercanidipine hydrochloride structure and therefore there is very strong lipophilicity, Main Function is the L-type calcium channel on retardance vascular smooth muscle cell film, the calcium ion of inflow cell is reduced, thus vasodilator smooth muscle, hemangiectasis, reduce blood pressure, and there is the advantages such as lasting medicine, cardioselective is high, bad reaction is few, clinical be mainly used in treatment in, mild hypertension.Lercanidipine hydrochloride is almost insoluble in water, and dissolution test is the necessary component that Lercanidipine hydrochloride tablet quality controls.State Food and Drug Administration standard YBH03972010 adopts small-radius curve track, determined by ultraviolet spectrophotometry this product dissolution rate, ultraviolet method is to measure absorption value that the ultraviolet absorption value of whole dissolution fluid is Lercanidipine hydrochloride to calculate the content of Lercanidipine hydrochloride, the absorbing state of whole solution can not get rid of auxiliary material interference, dissolution medium also has impact to absorption measurement simultaneously, and therefore ultraviolet spectrophotometry lacks specificity.Existing about the bibliographical information of Lercanidipine hydrochloride assay in Lercanidipine hydrochloride sheet little, all adopt HPLC method, in assay method, its mobile phase all adds certain density triethylamine solution as tailingsuppressing reagent, and the appearance time of Lercanidipine hydrochloride is between 8-14 minute.Auxiliary material interference may be there is owing to adopting in national standard determined by ultraviolet spectrophotometry Lercanidipine hydrochloride sheet dissolution rate and specificity is strong, yet there are no the bibliographical information to Lercanidipine hydrochloride sheet dissolution determination.
Summary of the invention
In order to overcome above problem, the object of the invention is to set up a kind of efficient fast, the method for mensuration Lercanidipine hydrochloride sheet dissolution rate that specificity is strong.The method overcome existing ultraviolet method and measure the defect that there is additive of tablet and dissolution medium interference, can truer, accurately, the dissolution rate of the mensuration Lercanidipine hydrochloride of science.Other HPLC methods of the relatively existing bibliographical information of the method are more quick and easy, do not use the triethylamine added in additive method as tailingsuppressing reagent in mobile phase, thus can protective coloration spectrometer and chromatographic column; Mobile phase adopts permanent degree wash-out, does not use gradient elution, easy and simple to handle; In the method, the appearance time of Lercanidipine hydrochloride is 6 minutes, and Lercanidipine hydrochloride peak shape is good, and post effect is high, and analysis time is all short compared with other analytical approachs, and can analyze in room temperature range.The method compares the interference that national standard determined by ultraviolet spectrophotometry can get rid of auxiliary material and dissolution medium simultaneously, can more accurately, objectively measure the dissolution rate of Lercanidipine hydrochloride sheet, various test shows that the method specificity is strong, result accurately, good stability, easy and simple to handle, be more suitable for the mensuration of said preparation dissolution rate, the quality of control Lercanidipine hydrochloride sheet that can be more scientific.
A kind of HPLC method measuring Lercanidipine hydrochloride sheet dissolution rate of the present invention, follows these steps to carry out:
(1) Lercanidipine hydrochloride sheet dissolution test and sample solution preparation: get Lercanidipine hydrochloride sheet 6, according to Chinese Pharmacopoeia version in 2010 two annex XC second methods, with the 0.1molL containing 0.3% Tween 80
-1hydrochloric acid solution 500mL is dissolution medium, and rotating speed is 50rmin
-1, operate in accordance with the law, through 45min, get solution 0.45 μm of miillpore filter and filter as sample solution;
(2) Lercanidipine hydrochloride reference substance solution preparation: get Lercanidipine hydrochloride reference substance appropriate, accurately weighed, add methyl alcohol 5mL and dissolve, add dissolution medium and quantitatively dilute the solution product solution in contrast made about containing 20 μ g in every 1mL;
(3) high-performance liquid chromatogram determination: get reference substance solution and sample solution carries out determination and analysis under following chromatographic condition, chromatographic column is Waters SunFire C
18; Mobile phase is 0.15molL
-1sodium perchlorate solution's (regulating pH to be 3.0 ~ 4.0 with 70% perchloric acid): acetonitrile (40: 60); Column temperature 25 ~ 30 DEG C; Determined wavelength 240nm; Flow velocity 1.0mlmin
-1; Reference substance solution and sample solution each sample introduction 40 μ L, adopt typical curve standard measure, and chromatogram record is completed by workstation with process.
Under the process conditions, Lercanidipine hydrochloride appearance time is about 6 minutes, Lercanidipine hydrochloride linear test, precision test, and stability test etc. all meet analysis requirement, and theoretical cam curve calculates by Lercanidipine hydrochloride peak and is not less than 6000.The method specificity is good, stable, the determined by ultraviolet spectrophotometry Lercanidipine hydrochloride sheet dissolution rate compared in national standard can get rid of the interference of additive of tablet and dissolution medium, other methods measuring Lercanidipine hydrochloride of relative bibliographical information are more easy and quick, the method can true, accurately, the dissolution rate of the mensuration Lercanidipine hydrochloride sheet of science, more effective drug quality to be controlled.
Accompanying drawing explanation
Fig. 1 Lercanidipine hydrochloride sheet blank chromatogram
Fig. 2 Lercanidipine hydrochloride reference substance solution chromatogram (1. Lercanidipine hydrochloride)
Fig. 3 Lercanidipine hydrochloride sheet dissolution rate sample solution (1. Lercanidipine hydrochloride)
The stripping curve figure of Fig. 4 Lercanidipine hydrochloride sheet
Embodiment
By following examples, further illustrate the present invention, but not as limitation of the present invention.
Embodiment 1
1 instrument and reagent
Waters 2695 type high performance liquid chromatograph; Switzerland SOTAXAT7smart digestion instrument (SOTAX company of Switzerland), FODT-601 type optical fiber drug dissolution the real time measure instrument (the rich Cohan Analytical Instrument Co., Ltd in Xinjiang).Lercanidipine hydrochloride sheet (specification 10mg/ sheet, lot number 110901,111001,111002) and Lercanidipine hydrochloride Working Control product (content 99.7%) provide by Chongqing Shenghuaxi Pharmaceutical Co., Ltd..Acetonitrile is chromatographically pure (Shandong Yu Wang industry main office chemical plant), and it is pure that other reagent are analysis.
2 methods and result
2.1 chromatographic condition
Chromatographic column is Waters SunFire C
18(4.6mm × 150mm, 5 μm); Mobile phase is 0.15molL
-1sodium perchlorate solution's (by 70% perchloric acid adjust ph to 3.0)-acetonitrile (40: 60); Column temperature 25 DEG C; Determined wavelength 240nm; Flow velocity 1.0mlmin
-1; Sample size 40 μ L.Theoretical cam curve calculates by Lercanidipine hydrochloride peak and is not less than 6000.
2.2 interference tests
Get each 1 of the blank of Lercanidipine hydrochloride sheet sample and not hydrochloric Lercanidipine, put respectively in stripping rotor, according to dissolution method operation herein, separately get Lercanidipine hydrochloride reference substance and add mobile phase and dissolve and make 40 μ gmL
-1reference substance solution.By the sample introduction 40 μ L respectively of chromatographic condition under " 2.1 " item, result shows that Lercanidipine hydrochloride goes out peak place and occurs without any chromatographic peak, show blank auxiliary and dissolution medium noiseless to measuring, the results are shown in Figure 1.
2.3 linear test
Precision takes Lercanidipine hydrochloride reference substance 0.01018g, puts in 50mL measuring bottle, adds methyl alcohol and dissolves and be diluted to scale with dissolution medium, shake up, in contrast product storing solution, precision measures 0.5,1,2,4,6,8,10mL, put in 50mL measuring bottle, add stripping medium to scale, shake up, both obtaining concentration is 2.036 ~ 40.72 μ gmL
-1control series product solution.Measure, with peak area A to C (μ gmL by chromatographic condition under " 2.1 " item
-1) carry out linear regression.In signal to noise ratio (S/N ratio) S/N>=10, be quantitatively limited to 0.13 μ μm L
-1, regression equation is: Y=39449.6C-592.8 (r=0.9999), and result shows, Lercanidipine hydrochloride concentration is at 2.036 ~ 40.72 μ gmL
-1scope is interior is good linear relationship with peak area.
2.4 precision test
Getting concentration is 20.36 μ gmL
-1reference substance solution, repeat sample introduction 6 times, RSD is 0.03%, meets precision test requirement.
2.5 stability test
Get the need testing solution under " 2.2 ", ambient temperatare sets to 0,1,2,4,6,8h, and sample introduction measures peak area respectively, and RSD=0.39%, shows that need testing solution is basicly stable in 8h.
2.6 recovery test
Get Lercanidipine hydrochloride reference substance about 8,10,12mg, accurately weighed, put in 50mL measuring bottle, add blank auxiliary by recipe quantity, dissolve with dissolution medium and be diluted to scale, shake up, filter, precision measures subsequent filtrate 5mL and puts in 100mL measuring bottle, add stripping medium to scale, shake up, measure by chromatographic condition under " 2.1 " item, calculate the recovery by external standard method.Result average recovery rate is 100.18%, RSD=0.98% (n=9).
3 stripping curves measure
For increasing work efficiency, FODT-601 type optical fiber drug dissolution the real time measure instrument is adopted to determine the stripping curve of Lercanidipine hydrochloride sheet.
The foundation precision of 3.1 typical curves takes Lercanidipine hydrochloride reference substance 0.02009g, puts in 25mL measuring bottle, adds stripping medium dissolves and be diluted to scale, shake up, precision measures 1, and 2.5,4,5mL, puts in 200mL measuring bottle, add stripping medium to scale, shake up, obtaining concentration (representing with stripping percent) is 20%, 50%, the control series product solution of 80%, 100%.Take dissolution medium as blank solvent, adopt the fibre-optical probe of 5mm specification.Determined wavelength selects 357nm, and reference wavelength 550nm, measures absorbance respectively, carries out linear regression (see table 1) with dissolution rate number percent (C) and absorbance (A).
The linear equation of table 16 passages and related coefficient
The mensuration of 3.2 stripping curves
Adopt FODT-601 Hexamermis spp type optical fiber drug dissolution the real time measure instrument, according to Chinese Pharmacopoeia version in 2010 two annex dissolution methods, with the 0.1molL containing 0.3% (w/v) Tween-80
-1hydrochloric acid solution 500mL is dissolution medium, and rotating speed is 50rmin
-1, adopt the fibre-optical probe of 5mm specification, determined wavelength 357nm, reference wavelength 550nm, automatically record absorbance by the every 1min of computing machine and calculate accumulative stripping quantity (%), the results are shown in Figure 4.Result shows, and under this test condition, during 45min, sample can stripping completely, and stripping curve is tending towards level, therefore sampling selection 45min is rational.
4 HPLC methods measure the dissolution rate of Lercanidipine hydrochloride sheet
Get this product 6, according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex XC dissolution methods), with the 0.1molL containing 0.3% (w/v) Tween 80
-1hydrochloric acid solution 500mL is dissolution medium, and rotating speed is 50rmin
-1, operate in accordance with the law, through 45min, get solution 0.45 μm of miillpore filter and filter as need testing solution; Separately get Lercanidipine hydrochloride reference substance appropriate, accurately weighed, add methyl alcohol 5mL and dissolve, add dissolution medium and quantitatively dilute the solution product solution in contrast made about containing 20 μ g in every 1mL.Precision measures above-mentioned two kinds of solution 40 μ L respectively, and injection liquid chromatography, by external standard method with the stripping quantity of the every sheet of calculated by peak area, limit is decided to be 75% of labelled amount.Continuous 3 sample lots dissolution determination results with according to State Food and Drug Administration standard YBH03972010 (determined by ultraviolet spectrophotometry) measurement result in table 2, Fig. 3.
Table 23 batch sample measures dissolution results by two kinds of methods
5 discuss
5.1 Lercanidipine hydrochlorides are almost insoluble in water, and dissolution medium, containing 0.3% (w/v) Tween 80, increases the solubleness of Lercanidipine hydrochloride, 50rmin while avoiding with an organic solvent
-1stirring intensity and person in middle and old age's human body gastrointestinal motility intensity suitable, this product user is mostly the elderly, therefore this rotating speed first-selected, and the Dissolution Rate Testing condition adopted herein meets specification and the convention of Japanese orange paper.
5.2 Lercanidipine hydrochlorides with dissolution medium (containing the 0.1molL of 0.3% (w/v) Tween 80
-1hydrochloric acid solution) dissolve after have absorption maximum at the wavelength salt of 259nm and 361nm, the absorbance at 59nm place is about 1.6 times of 361nm place, but the Tween-80 in dissolution medium has remarkable interference in low wavelength coverage.Select the strong 240nm of Lercanidipine hydrochloride absorbance to improve detection sensitivity as determined wavelength in the method for the high effective liquid chromatography for measuring dissolution rate that the present invention sets up, the interference of Tween-80 in dissolution medium can be got rid of simultaneously.
5.5 3 batch sample dissolution rates are all on prescribed limit (75%), but each batch of product asks to there is significant difference, and it is low by 3% ~ 4% that HPLC method measures the result of dissolution rate than UV method, may can not to get rid of the interference of auxiliary material and dissolution medium relevant with UV method.The high effective liquid chromatography for measuring Lercanidipine hydrochloride sheet dissolution method set up herein has higher specificity and sensitivity, and result is accurate, good stability, is more suitable for the mensuration of said preparation dissolution rate.
Embodiment 2
2.1 chromatographic condition
Chromatographic column is Waters SunFire C
18(4.6mm × 150mm, 5 μm); Mobile phase is 0.15molL
-1sodium perchlorate solution's (by 70% perchloric acid adjust ph to 4.0)-acetonitrile (40: 60); Column temperature 25 DEG C; Determined wavelength 240nm; Flow velocity 1.0mlmin
-1; Sample size 40 μ L.Theoretical cam curve calculates by Lercanidipine hydrochloride peak and is not less than 6000.
4 sample dissolution determinations
Get this product 6, according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex XC dissolution methods), with the 0.1molL containing 0.3% (w/v) Tween 80
-1hydrochloric acid solution 500mL is dissolution medium, and rotating speed is 50rmin
-1, operate in accordance with the law, through 45min, get solution 0.45 μm of miillpore filter and filter as need testing solution; Separately get Lercanidipine hydrochloride reference substance appropriate, accurately weighed, add methyl alcohol 5mL and dissolve, add dissolution medium and quantitatively dilute the solution product solution in contrast made about containing 20 μ g in every 1mL.Precision measures above-mentioned two kinds of solution 40 μ L respectively, and injection liquid chromatography, by external standard method with the stripping quantity of the every sheet of calculated by peak area, limit is decided to be 75% of labelled amount.Continuous 3 sample lots dissolution determination results with according to State Food and Drug Administration standard YBH03972010 (determined by ultraviolet spectrophotometry) measurement result in table 3.
Table 33 batch sample measures dissolution results by two kinds of methods
All the other operations are with embodiment 1.
Embodiment 3
2.1 chromatographic condition
Chromatographic column is Waters SunFire C
18(4.6mm × 150mm, 5 μm); Mobile phase is 0.15molL
-1sodium perchlorate solution's (by 70% perchloric acid adjust ph to 3.0)-acetonitrile (40: 60); Column temperature 30 DEG C; Determined wavelength 240nm; Flow velocity 1.0mlmin
-1; Sample size 40 μ L.Theoretical cam curve calculates by Lercanidipine hydrochloride peak and is not less than 6000.
4 sample dissolution determinations
Get this product 6, according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex XC dissolution methods), with the 0.1molL containing 0.3% (w/v) Tween 80
-1hydrochloric acid solution 500mL is dissolution medium, and rotating speed is 50rmin
-1, operate in accordance with the law, through 45min, get solution 0.45 μm of miillpore filter and filter as need testing solution; Separately get Lercanidipine hydrochloride reference substance appropriate, accurately weighed, add methyl alcohol 5mL and dissolve, add dissolution medium and quantitatively dilute the solution product solution in contrast made about containing 20 μ g in every 1mL.Precision measures above-mentioned two kinds of solution 40 μ L respectively, and injection liquid chromatography, by external standard method with the stripping quantity of the every sheet of calculated by peak area, limit is decided to be 75% of labelled amount.Continuous 3 sample lots dissolution determination results with according to State Food and Drug Administration standard YBH03972010 (determined by ultraviolet spectrophotometry) measurement result in table 4.
Table 43 batch sample measures dissolution results by two kinds of methods
All the other operations are with embodiment 1.
Embodiment 4
2.1 chromatographic condition
Chromatographic column is Waters SunFire C
18(4.6mm × 150mm, 5 μm); Mobile phase is 0.15molL
-1sodium perchlorate solution's (by 70% perchloric acid adjust ph to 4.0)-acetonitrile (40: 60); Column temperature 30 DEG C; Determined wavelength 240nm; Flow velocity 1.0mlmin
-1; Sample size 40 μ L.Theoretical cam curve calculates by Lercanidipine hydrochloride peak and is not less than 6000.
4 sample dissolution determinations
Get this product 6, according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex XC dissolution methods), with the 0.1molL containing 0.3% (w/v) Tween 80
-1hydrochloric acid solution 500mL is dissolution medium, and rotating speed is 50rmin
-1, operate in accordance with the law, through 45min, get solution 0.45 μm of miillpore filter and filter as need testing solution; Separately get Lercanidipine hydrochloride reference substance appropriate, accurately weighed, add methyl alcohol 5mL and dissolve, add dissolution medium and quantitatively dilute the solution product solution in contrast made about containing 20 μ g in every 1mL.Precision measures above-mentioned two kinds of solution 40 μ L respectively, and injection liquid chromatography, by external standard method with the stripping quantity of the every sheet of calculated by peak area, limit is decided to be 75% of labelled amount.Continuous 3 sample lots dissolution determination results with according to State Food and Drug Administration standard YBH03972010 (determined by ultraviolet spectrophotometry) measurement result in table 5.
Table 53 batch sample measures dissolution results by two kinds of methods
All the other operations are with embodiment 1.
Claims (1)
1. measure a HPLC method for Lercanidipine hydrochloride sheet dissolution rate, it is characterized in that comprising the following steps:
(1) Lercanidipine hydrochloride sheet Dissolution Rate Testing and sample solution preparation: get Lercanidipine hydrochloride sheet 6, according to Chinese Pharmacopoeia version in 2010 two annex XC dissolution methods, with the 0.1molL containing 0.3% Tween 80
-1hydrochloric acid solution 500mL is dissolution medium, and rotating speed is 50rmin
-1, operate in accordance with the law, through 45min, get solution 0.45 μm of miillpore filter and filter as sample solution;
(2) Lercanidipine hydrochloride reference substance solution preparation: get Lercanidipine hydrochloride reference substance appropriate, accurately weighed, add methyl alcohol 5mL and dissolve, add dissolution medium and quantitatively dilute the solution product solution in contrast made about containing 20 μ g in every 1mL;
(3) high-performance liquid chromatogram determination: get reference substance solution and sample solution carries out determination and analysis under following chromatographic condition, chromatographic column is Waters SunFire C
18; Mobile phase is the 0.15molL of 3.0 ~ 4.0 by 70% perchloric acid adjust ph
-1the ratio of sodium perchlorate solution and acetonitrile is 40: 60 compositions; Column temperature 25 ~ 30 DEG C; Determined wavelength is 240mm; Flow velocity is 1.0mlmin
-1; Reference substance solution and sample solution each sample introduction 40 μ L, adopt typical curve standard measure, and chromatogram record is completed by workstation with process, and theoretical cam curve calculates by Lercanidipine hydrochloride peak and is not less than 6000.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105319298A (en) * | 2015-10-09 | 2016-02-10 | 北京万全德众医药生物技术有限公司 | Method for separating and measuring related substances of lercanidipine hydrochloride midbody through liquid chromatography |
| CN106483203A (en) * | 2015-08-27 | 2017-03-08 | 扬子江药业集团南京海陵药业有限公司 | Epalrestat tablet dissolution determination method |
| CN117169392A (en) * | 2023-11-03 | 2023-12-05 | 华润双鹤利民药业（济南）有限公司 | Pretreatment method for detecting impurity content in nifedipine controlled release tablet, detection method and application thereof |
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| WO2007120135A1 (en) * | 2006-04-17 | 2007-10-25 | Forest Laboratories, Inc. | Lercanidipine immediate release composition |
| CN103505461A (en) * | 2012-06-19 | 2014-01-15 | 深圳信立泰药业股份有限公司 | Solid medicine composition of lercanidipine and benazepril |
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| WO2007120135A1 (en) * | 2006-04-17 | 2007-10-25 | Forest Laboratories, Inc. | Lercanidipine immediate release composition |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106483203A (en) * | 2015-08-27 | 2017-03-08 | 扬子江药业集团南京海陵药业有限公司 | Epalrestat tablet dissolution determination method |
| CN105319298A (en) * | 2015-10-09 | 2016-02-10 | 北京万全德众医药生物技术有限公司 | Method for separating and measuring related substances of lercanidipine hydrochloride midbody through liquid chromatography |
| CN117169392A (en) * | 2023-11-03 | 2023-12-05 | 华润双鹤利民药业（济南）有限公司 | Pretreatment method for detecting impurity content in nifedipine controlled release tablet, detection method and application thereof |
| CN117169392B (en) * | 2023-11-03 | 2024-01-26 | 华润双鹤利民药业（济南）有限公司 | Pretreatment method for detecting impurity content in nifedipine controlled release tablet, detection method and application thereof |
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Application publication date: 20150729 |