CN104569172A - Method for detecting dissolution rate of alogliptin benzoate tablets by using liquid chromatography - Google Patents
Method for detecting dissolution rate of alogliptin benzoate tablets by using liquid chromatography Download PDFInfo
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Abstract
The invention provides a method for detecting dissolution rate of alogliptin benzoate tablets. The method comprises the following steps: by adopting a Welch Ultimate AQ-C18 5-micron chromatographic column of 4.6*150mm, taking a mixed solution of phosphate aqueous solution with the pH value of 5.5-6.5 and acetonitrile as a mobile phase, performing isocratic elution, and detecting the dissolution rate of the alogliptin benzoate tablets on the liquid chromatography system. The detection method provided by the invention is economic, rapid and high-efficiency, has high specificity and is suitable for detecting the dissolution rate of the alogliptin benzoate tablets under different dissolution medium conditions.
Description
Technical field
The invention belongs to field of medicine and chemical technology, relate more specifically to a kind of method of liquid chromatographic detection SYR-322 sheet dissolution rate.
Background technology
SYR-322, chemistry 2-(6-((3R)-3-amino piperidine-1-base)-3-methyl-2,4-dioxy-3,4-dihydro-pyrimidin-1 (2H) base) methyl by name) cyanobenzene list benzoate, structural formula:
Chemical formula: C
18h
21n
5o
2c
7h
6o
2molecular weight: 461.5
It is serine protease DPP IV (DPP-IV) inhibitor, the level of glucagon-like peptide 1 in body (GLP-1) and glucose-dependent-insulinotropic polypeptide (GIP) can be maintained, promote the secretion of insulin, thus play hypoglycemic curative effect.SYR-322 is used for the treatment of the purposes of diabetes B known by masses, and it is used for the treatment of the respond well of diabetes B.At present, the tablet that the Egelieting medicine ratifying to go on the market at home has Japanese Takeda Pharmaceutical Company Limited to produce, Ni Xinna (Nesina); Domestic many SYR-322 sheet imitation medicines are in examining.
In the oral tablet quality control of medicine, check that the dissolution rate situation of oral tablet is absolutely necessary a ring.The situation of medicinal tablet release in vitro of (simulation human gastrointestinal tract dissolves the environment of tablet) under different dissolution medium condition can be investigated, indirect assessment medicinal tablet release mode in vivo by the dissolution rate measuring oral tablet.In this medicinal tablet body, the appraisal procedure of release conditions is a kind of conventional method, and the condition of concrete Dissolution Rate Testing is all documented in detail in the current edition pharmacopeia of various countries.
But the dissolution rate accurately detecting different pharmaceutical tablet ensures that Dissolution experiments is basic accurately and reliably.Have been reported the method for detecting SYR-322 content in the prior art.
The Chinese import drugs registered standard of the Egelieting sheet of Yuan Yan Takeda Pharmaceutical Company Limited, standard No.: JX20120216, discloses the chromatographic column (4.6mm × 150mm, 5 μm) adopting cyanoalkysilane bonded silica gel as Stationary liquid; With water-acetonitrile-trifluoroacetic acid (1800:200:1) for mobile phase, determined wavelength is 278nm, and column temperature is 35 DEG C, carries out the content assaying method of isocratic elution.In chromatogram under described method detects, the retention time at Egelieting peak is about 10.5 minutes.Because cyanoalkysilane bonded-phase silica is relative to octadecylsilane bonded-phase silica less stable, and have employed the very strong trifluoroacetic acid of corrosivity due to mobile phase, its repeatability in daily analyte detection process is poor, and pillar easily damages.The chromatographic column price of cyanoalkysilane bonded-phase silica is also costly late with Egelieting appearance time in addition.
Chinese patent application CN 103156819 A benzoic acid alogliptin composition troche and preparation method thereof, discloses a kind of content assaying method: chromatographic column in the description: YMC C18 post; Mobile phase: acetonitrile-0.1% perchloric acid (containing 0.3% triethylamine) (pH=3.0)=20:80; Determined wavelength: 224nm; Column temperature: 30 DEG C; Sample size: 20 μ l.Described method have employed the very strong perchloric acid preparation mobile phase of oxidisability, and it has very large corrosivity to chromatographic column and instrument, is not suitable for the routine testing of Drug's control; Perchloric acid due to high concentration has very strong oxidisability and corrosivity, and therefore storage perchloric acid in laboratory is inconvenient, prepares also safe not.Therefore described method neither detect the desirable method of SYR-322 tablet content.
The Chinese patent application CN 103353491 A mono-kind method of liquid chromatography for separating and determining SYR-322 raw material and preparation thereof.The feature of described method is as follows: the model of high performance liquid chromatograph, has no special requirements, and the chromatograph that the present invention adopts is Shimadzu LC-20ATvp, SPD-M20Avp; Chromatographic column: C8 (Apollo, 250 × 4.6mm, 5 μm); Mobile phase: A: potassium phosphate buffer (take 2.72gKH2PO4,0.94g sodium hexanesulfonate, the 1000ml that adds water makes dissolving, and KOH solution regulates pH to 5.5); B: methyl alcohol;
Adopt gradient elution
Table 1
| Time (min) | A％(v/v) | A％(v/v) |
| 0 | 85 | 15 |
| 5 | 85 | 15 |
| 15 | 65 | 35 |
| 25 | 50 | 50 |
| 30 | 50 | 50 |
| 40 | 85 | 15 |
| 50 | 85 | 15 |
Flow velocity: 1.0mL/min; Determined wavelength: 215nm; Column temperature: 20 DEG C; Sampling volume: 10 μ L.Egelieting appearance time is about 28min.The method mobile phase have employed the reagent such as ion-pairing agent sodium hexanesulfonate, potassium dihydrogen phosphate box potassium hydroxide, and composition is complicated; The method additionally uses gradient elution, and detection time is long, is not suitable for the dissolution rate of Fast Measurement SYR-322 sheet.
In order to overcome the deficiency that present analysis method exists, the invention provides a kind of detection method that can be used in detecting SYR-322 sheet dissolution rate under multiple dissolution medium experiment condition.
Summary of the invention
Summary of the invention
The present inventor is attempted by test of many times, by screening different chromatographic columns and coordinating the mobile phase condition adapted to obtain a kind of method being applicable to SYR-322 sheet dissolution rate and detecting with hope.Final discovery adopts Welch Ultimate AQ-C18,4.6 × 150mm, 5 μm of chromatographic columns, and adopt the aqueous phosphatic of about pH 5.5 ~ 6.5 and the mixed solution of acetonitrile to carry out isocratic elution as mobile phase can effectively to detect SYR-322 Dissolution of Tablet.The chromatogram peak-to-peak type that this combination can make to detect the Egelieting under different dissolution medium is good, and appearance time is fast, and specificity is good.The SYR-322 dissolution determination method that the invention provides a kind of easy, efficiency, economy and be suitable for.
Term definition
During term " peak purity " refers to that HPLC detects, for judging whether a certain chromatographic peak is the investigation parameter caused by a material, namely general peak purity thinks that between 0.990 ~ 1.000 investigated a certain chromatographic peak is pure, and this chromatographic peak is the chromatographic peak of certain one matter.
Term " about " refer in the present invention described numerical value ± 10% within.
To refer in term " rpm " the present invention rev/min.
Detailed Description Of The Invention
A kind of SYR-322 sheet dissolution detection method provided by the invention, is characterized in that:
Described method is carried out on high performance liquid chromatograph;
Chromatographic column is Welch Ultimate AQ-C18,4.6 × 150mm, 5 μm;
Mobile phase is potassium dihydrogen phosphate aqueous solution and acetonitrile mixed solution, and wherein the pH value of potassium dihydrogen phosphate aqueous solution is about 5.5 ~ 6.5, and the volume ratio of potassium dihydrogen phosphate aqueous solution and acetonitrile is about 70:30 ~ 80:20.
Wherein, detecting device can be UV detecting device, and determined wavelength is 278nm; Flow velocity can be 0.2 ~ 2.0ml/min; Sample size is 5 ~ 100 μ L; Column temperature is room temperature; Working time can be about 5 ~ 10min.
In certain embodiments, potassium dihydrogen phosphate aqueous solution concentration of the present invention is about 6.805g/L, and pH value is about 6.0.
In certain embodiments, described is about 75:25 as the volume ratio of potassium dihydrogen phosphate aqueous solution and acetonitrile in the mixed solution of mobile phase.
In certain embodiments, described column temperature is 20 DEG C ~ 30 DEG C, or 25 DEG C.
In certain embodiments, method of the present invention is the dissolution rate in 0.01N hydrochloric acid solution for detecting SYR-322 sheet at dissolution medium.
In certain embodiments, method of the present invention is the dissolution rate in 0.1N hydrochloric acid solution for detecting SYR-322 sheet at dissolution medium.
In certain embodiments, method of the present invention, for detecting SYR-322 sheet at the dissolution medium dissolution rate that to be pH be in the Acetate Solution of 4.5, is sodium acetate solution in certain embodiments.
In certain embodiments, method of the present invention, for detecting SYR-322 sheet at the dissolution medium dissolution rate that to be pH be in the phosphate solution of 6.8, is phosphate sodium solution in certain embodiments.
In certain embodiments, SYR-322 sheet dissolution detection method of the present invention, is characterized in that:
Described method is carried out on Agilent 1260 high performance liquid chromatograph;
Chromatographic column is Welch Ultimate AQ-C18,4.6 × 150mm, 5 μm;
Detecting device is UV detecting device, and determined wavelength is 278nm;
Flow velocity is 1.0ml/min;
Sample size is 20 μ L;
Column temperature is 25 DEG C;
Working time is about 5min;
Mobile phase is potassium dihydrogen phosphate aqueous solution and acetonitrile mixed solution, and wherein the concentration of potassium dihydrogen phosphate aqueous solution is about 6.805g/L, and pH value is about 6.0; The volume ratio of potassium dihydrogen phosphate aqueous solution and acetonitrile is about 75:25.
A kind of SYR-322 sheet dissolution detection method of the present invention be applicable to detecting SYR-322 sheet 0.01N hydrochloric acid solution, 0.1N hydrochloric acid solution, pH be 4.5 sodium acetate solution or pH be that the phosphate sodium solution of 6.8 is as the dissolution rate in dissolution medium.
Accompanying drawing explanation
Fig. 1 shows the chromatogram of embodiment 1-4 empty solution
Fig. 2 shows that in embodiment 1,0.01N hydrochloric acid solution is as the dissolution rate chromatogram of the SYR-322 sheet sample of dissolution medium
Fig. 3 shows that in embodiment 2,0.1N hydrochloric acid solution is as the dissolution rate chromatogram of the SYR-322 sheet sample of dissolution medium
Fig. 4 shows the dissolution rate chromatogram of the sodium acetate solution of pH4.5 in embodiment 3 as the SYR-322 sheet sample of dissolution medium
Fig. 5 shows the dissolution rate chromatogram of the phosphate sodium solution of pH6.8 in embodiment 4 as the SYR-322 sheet sample of dissolution medium
Embodiment
In order to make those skilled in the art understand technical scheme of the present invention better, below disclose further some non-limiting embodiments the present invention is described in further detail.
Reagent used in the present invention all can be buied from the market or can be obtained by method described in the invention preparation.
Embodiment 1
With reference to " Chinese Pharmacopoeia " version (two) dissolution method (annex Ⅹ C second method) in 2010, specific as follows:
In U.S. distek6300 digestion instrument, using 0.01N hydrochloric acid solution as dissolution medium, 900 ± 9ml, paddle method, rotating speed is about 50rpm, and temperature about 37.0 ± 0.5 DEG C, carries out Dissolution experiments by SYR-322 sheet (Nesina).By the planned time of regulation, add pot strainer and sample, then adopt high performance liquid chromatography to carry out dissolution rate detection.
Analytical approach:
Instrument: Agilent 1260 high performance liquid chromatograph;
Chromatographic column is Welch Ultimate AQ-C18,4.6 × 150mm, 5 μm;
Detecting device is UV detecting device, and determined wavelength is 278nm;
Flow velocity is 1.0ml/min;
Sample size is 20 μ L;
Column temperature is 25 DEG C;
Working time is about 5min;
Mobile phase is potassium dihydrogen phosphate aqueous solution and acetonitrile mixed solution, and wherein the concentration of potassium dihydrogen phosphate aqueous solution is about 6.805g/L, and pH value is about 6.0; The volume ratio of potassium dihydrogen phosphate aqueous solution and acetonitrile is about 75:25.
Blank solution: the dissolution medium that 0.01N salt is acid-soluble.
Need testing solution: in the sampling of regulation sampling time point, filter, go subsequent filtrate as test liquid.
Blank solution and need testing solution are pressed above-mentioned analytical approach sample detection, record chromatogram.Collection of illustrative plates is as Fig. 1 and Fig. 2.In Fig. 2, retention time is the peak of 2.307min is benzoic acid peak; Retention time is the peak of 3.473min is Egelieting peak.Symmetry and the degree of separation at Egelieting peak all meet pharmacopoeial requirements.Testing result is as table 2.
Table 2
Embodiment 2
With reference to " Chinese Pharmacopoeia " version (two) dissolution method (annex Ⅹ C second method) in 2010, specific as follows:
In U.S. distek6300 digestion instrument, using 0.1N hydrochloric acid solution as dissolution medium, 900 ± 9ml, paddle method, rotating speed is about 50rpm, and temperature about 37.0 ± 0.5 DEG C, carries out Dissolution experiments by SYR-322 sheet (Nesina).By the planned time of regulation, add pot strainer and sample, then adopt high performance liquid chromatography to carry out dissolution rate detection.
Analytical approach analytical approach as described in example 1 above.
Blank solution: the dissolution medium that 0.1N salt is acid-soluble.
Need testing solution: in the sampling of regulation sampling time point, filter, go subsequent filtrate as test liquid.
Blank solution and need testing solution are pressed above-mentioned analytical approach sample detection, record chromatogram.Collection of illustrative plates is as Fig. 1 and Fig. 3.In Fig. 3, retention time is the peak of 2.700min is benzoic acid peak; Retention time is the peak of 3.873min is Egelieting peak.Symmetry and the degree of separation at Egelieting peak all meet pharmacopoeial requirements.Testing result is as table 3.
Table 3
Embodiment 3
With reference to " Chinese Pharmacopoeia " version (two) dissolution method (annex Ⅹ C second method) in 2010, specific as follows:
In U.S. distek6300 digestion instrument, using pH be the sodium acetate solution of 4.5 as dissolution medium, 900 ± 9ml, paddle method, rotating speed is about 50rpm, and temperature about 37.0 ± 0.5 DEG C, carries out Dissolution experiments by SYR-322 sheet (Nesina).By the planned time of regulation, add pot strainer and sample, then adopt high performance liquid chromatography to carry out dissolution rate detection.
Analytical approach analytical approach as described in example 1 above.
Blank solution: the dissolution medium of sodium acetate solution (pH4.5).
Need testing solution: in the sampling of regulation sampling time point, filter, go subsequent filtrate as test liquid.
Blank solution and need testing solution are pressed above-mentioned analytical approach sample detection, record chromatogram.Collection of illustrative plates is as Fig. 1 and Fig. 4.In Fig. 4, retention time is the peak of 2.333min is benzoic acid peak; Retention time is the peak of 3.413min is Egelieting peak.Symmetry and the degree of separation at Egelieting peak all meet pharmacopoeial requirements.
Testing result is as table 4.
Table 4
Embodiment 4
With reference to " Chinese Pharmacopoeia " version (two) dissolution method (annex Ⅹ C second method) in 2010, specific as follows:
In U.S. distek6300 digestion instrument, using pH be the phosphate sodium solution of 6.8 as dissolution medium, 900 ± 9ml, paddle method, rotating speed is about 50rpm, and temperature about 37.0 ± 0.5 DEG C, carries out Dissolution experiments by SYR-322 sheet (Nesina).By the planned time of regulation, add pot strainer and sample, then adopt high performance liquid chromatography to carry out dissolution rate detection.
Analytical approach analytical approach as described in example 1 above.
Blank solution: the dissolution medium of phosphate sodium solution (pH6.8)
Need testing solution: in the sampling of regulation sampling time point, filter, go subsequent filtrate as test liquid.
Blank solution and need testing solution are pressed above-mentioned analytical approach sample detection, record chromatogram.Collection of illustrative plates is as Fig. 1 and Fig. 5.In Fig. 5, retention time is the peak of 2.313min is benzoic acid peak; Retention time is the peak of 3.487min is Egelieting peak.Symmetry and the degree of separation at Egelieting peak all meet pharmacopoeial requirements.
Testing result is as table 5.
Table 5
To sum up described in embodiment 1-4, SYR-322 sheet dissolution detection method provided by the invention, measure dissolution medium be 0.01N hydrochloric acid solution respectively, 0.1N hydrochloric acid solution, pH be about 4.5 sodium acetate solution or pH be in the SYR-322 sheet Dissolution experiments of the phosphate sodium solution of about 6.8, there is good tolerance.
Detect in collection of illustrative plates at each blank sample, show that going out peak place at Egelieting chromatographic peak does not have Interference Peaks, collection of illustrative plates is clean, can not cause interference to Egelieting sample detection.
Detect in collection of illustrative plates in each sample, Egelieting chromatogram peak-to-peak type is symmetrical, and symmetrical factor is between 1.00 ~ 1.20; Peak purity is high, and Egelieting peak purity is 1.000, shows that Egelieting chromatographic peak does not comprise the chromatographic peak of other impurity; The degree of separation of Egelieting chromatographic peak and adjacent chromatographic peak is between 6 ~ 7, and degree of separation is good; Egelieting chromatographic peak appearance time only 3 ~ 4min, quickly.
Therefore, method provided by the invention is easy, efficient, specificity is good.
Method of the present invention is described by preferred embodiment, and related personnel obviously can change methods and applications as herein described or suitably change and combination in content of the present invention, spirit and scope, realizes and applies the technology of the present invention.Those skilled in the art can use for reference present disclosure, and suitable improving technique parameter realizes.Special needs to be pointed out is, all similar replacements and change apparent to those skilled in the art, they are all deemed to be included in the present invention.
Claims (7)
1. a SYR-322 sheet dissolution detection method, is characterized in that:
Described method is carried out on high performance liquid chromatograph;
Chromatographic column is Welch Ultimate AQ-C18,4.6 × 150mm, 5 μm;
Mobile phase is potassium dihydrogen phosphate aqueous solution and acetonitrile mixed solution, and wherein the pH value of potassium dihydrogen phosphate aqueous solution is about 5.5 ~ 6.5, and the volume ratio of potassium dihydrogen phosphate aqueous solution and acetonitrile is about 70:30 ~ 80:20.
2. detection method according to claim 1, detecting device is UV detecting device, and determined wavelength is 278nm; Flow velocity is 0.2 ~ 2.0ml/min; Sample size is 5 ~ 100 μ L; Column temperature is room temperature; Working time is about 5 ~ 10min.
3. detection method according to claim 2, described room temperature is 20 DEG C ~ 30 DEG C.
4. detection method according to claim 1, described potassium dihydrogen phosphate aqueous solution concentration is about 6.805g/L, and pH value is about 6.0.
5. detection method according to claim 1, described is about 75:25 as the volume ratio of potassium dihydrogen phosphate aqueous solution and acetonitrile in the mixed solution of mobile phase.
6. a SYR-322 sheet dissolution detection method, is characterized in that:
Described method is carried out on Agilent 1260 high performance liquid chromatograph;
Chromatographic column is Welch Ultimate AQ-C18,4.6 × 150mm, 5 μm;
Detecting device is UV detecting device, and determined wavelength is 278nm;
Flow velocity is 1.0ml/min;
Sample size is 20 μ L;
Column temperature is 25 DEG C;
Working time is about 5min;
Mobile phase is potassium dihydrogen phosphate aqueous solution and acetonitrile mixed solution, and wherein the concentration of potassium dihydrogen phosphate aqueous solution is about 6.805g/L, and pH value is about 6.0; The volume ratio of potassium dihydrogen phosphate aqueous solution and acetonitrile is about 75:25.
7. according to the arbitrary described detection method of claim 1-6, described method for detect SYR-322 sheet using 0.01N hydrochloric acid solution, 0.1N hydrochloric acid solution, pH be 4.5 sodium acetate solution or pH be that the phosphate sodium solution of 6.8 is as the dissolution rate of dissolution medium.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106770731A (en) * | 2016-11-30 | 2017-05-31 | 无锡艾科瑞思产品设计与研究有限公司 | The detection method of benzoic acid in a kind of food |
| CN109580835A (en) * | 2018-12-31 | 2019-04-05 | 辰欣药业股份有限公司 | A method of with the related substance of liquid chromatography for separating and determining Egelieting |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106770731A (en) * | 2016-11-30 | 2017-05-31 | 无锡艾科瑞思产品设计与研究有限公司 | The detection method of benzoic acid in a kind of food |
| CN109580835A (en) * | 2018-12-31 | 2019-04-05 | 辰欣药业股份有限公司 | A method of with the related substance of liquid chromatography for separating and determining Egelieting |
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Application publication date: 20150429 |