CN115825287B - Method for measuring content of carboxymethyl starch sodium in lamivudine tablet - Google Patents
Method for measuring content of carboxymethyl starch sodium in lamivudine tablet Download PDFInfo
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- CN115825287B CN115825287B CN202211682314.5A CN202211682314A CN115825287B CN 115825287 B CN115825287 B CN 115825287B CN 202211682314 A CN202211682314 A CN 202211682314A CN 115825287 B CN115825287 B CN 115825287B
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Abstract
The invention discloses a method for measuring the content of carboxymethyl starch sodium in lamivudine tablets, which comprises the following steps: taking a linear test of sodium carboxymethyl starch, adding a diluent into the sodium carboxymethyl starch to obtain a plurality of linear solutions with different concentrations of 0.05-5 mg/ml, respectively injecting the solutions into a high performance liquid chromatograph, recording a chromatogram, carrying out linear regression on the sodium carboxymethyl starch concentration and the corresponding peak area, and calculating a standard curve; preparing a sample solution, taking 1 lamivudine tablet, weighing, placing in a measuring flask, and adding the diluent to dilute to the measuring flask scale to obtain the sample solution; and (3) detecting sodium carboxymethyl starch in the lamivudine tablet, injecting the solution of the test sample into a high performance liquid chromatograph, recording a chromatogram, and calculating the content of sodium carboxymethyl starch in the test sample according to a standard curve method by using a linear equation. The method improves the specificity problem of the existing detection method by adopting chromatographic separation and adopting an evaporative light scattering detector, an electric fog detector or a differential shading detector for detection.
Description
Technical Field
The invention relates to the technical field of biological medicine industry, in particular to a method for measuring the content of carboxymethyl starch sodium in lamivudine tablets.
Background
In the development of the imitation drug, quantitative and qualitative analysis is carried out on the auxiliary material composition of the reference preparation, so that reference can be provided for the development of the preparation, the success rate of the development of the imitation drug is greatly improved, and the process is reverse engineering. Because of the large difference of the properties of each auxiliary material and the complex chemical composition, the accurate qualitative and quantitative determination of the auxiliary material becomes one of the difficulties in the development of the imitation medicines at present.
Lamivudine tablets (trade name: EPIVIR) are produced by gram-positive-pressure tablet (Shikon) initially, and according to the specification of lamivudine tablets, the auxiliary materials comprise carboxymethyl starch sodium which is often used as a disintegrating agent of capsules and tablets in oral pharmaceutical preparations, and the sodium carboxymethyl starch is rapidly and remarkably swelled through rapid water absorption, so that the lamivudine tablets have a disintegrating effect, meanwhile have compressibility, can improve the formability of the tablets, increase the hardness of the tablets without affecting the disintegrating property, and are key auxiliary materials in preparation development, wherein the general dosage is 2% -8%. The method for measuring the sodium carboxymethyl starch content in the Chinese pharmacopoeia and the United states pharmacopoeia is an acid-base titration method, but because of the complex components in the preparation, the method is easy to be interfered by other components, and is not suitable for measuring the content of a small amount of sodium carboxymethyl starch in lamivudine tablets.
The information disclosed in this background section is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person of ordinary skill in the art.
Disclosure of Invention
The invention aims to provide a method for measuring the content of sodium carboxymethyl starch in lamivudine tablets, which can solve the problem that the content measurement of sodium carboxymethyl starch is interfered by other components.
In order to achieve the above purpose, the invention provides a method for measuring the content of carboxymethyl starch sodium in lamivudine tablets, which comprises the following steps:
(1) Taking a linear test of sodium carboxymethyl starch, adding 0.1mol/L sodium hydroxide solution of a diluent into the sodium carboxymethyl starch to 75% of the volume of a measuring flask, carrying out ultrasonic treatment for 1 hour, cooling to room temperature, diluting the solution to a plurality of linear solutions with different concentrations, which contain 0.05-5 mg/ml sodium carboxymethyl starch, by using the diluent, taking the linear solutions with different concentrations of sodium carboxymethyl starch, respectively injecting the linear solutions into a high performance liquid chromatograph, recording a chromatogram, carrying out linear regression on the concentration of sodium carboxymethyl starch and the corresponding peak area, and calculating a standard curve;
(2) Preparing a sample solution, weighing 1 lamivudine tablet, placing the sample solution into a measuring flask, adding a diluent to 75% of the volume of the measuring flask, performing ultrasonic treatment for 10-20 minutes, shaking for 10-20 minutes, adding the diluent to dilute to the measuring flask scale, shaking uniformly, swirling, centrifuging at 10000rpm for 5-15 minutes, and taking a supernatant to obtain the sample solution;
(3) And (3) detecting sodium carboxymethyl starch in the lamivudine tablet, injecting the sample solution obtained in the step (2) into a high performance liquid chromatograph, recording a chromatogram, and calculating the content of sodium carboxymethyl starch in the sample according to a standard curve method by utilizing the linear equation obtained in the step (1).
Further, the step (1) includes the following steps:
(0) Preparing a sodium carboxymethyl starch sodium exclusive test, preparing a blank solution of 0.1mol/L sodium hydroxide solution, preparing a reference substance solution, adding a diluent into the sodium carboxymethyl starch to 75% of the volume of a measuring flask, performing ultrasonic treatment for 1-1.5 hours, diluting the sodium carboxymethyl starch sodium into the reference substance solution containing 0.2mg/mL sodium carboxymethyl starch by using the diluent, taking the blank solution and the reference substance solution, injecting the blank solution and the reference substance solution into a high performance liquid chromatograph, recording a chromatogram, and judging the specificity of the sodium carboxymethyl starch content measuring method in the lamivudine tablet according to whether the blank solution has interference at the peak of sodium carboxymethyl starch.
Further, the step (3) includes the steps of:
(4) In the test of the accuracy of the test piece,
preparing a blank solution of 5mol/L sodium hydroxide solution,
preparing a reference substance solution: adding diluent into sodium carboxymethyl starch to 75% of the volume of a measuring flask, carrying out ultrasonic treatment for 1-1.5 hours, cooling to room temperature, diluting with the diluent to obtain a plurality of linear reference substance solutions with different concentrations of 0.05-5 mg/ml sodium carboxymethyl starch,
preparing a test solution: taking 1 piece of self-made lamivudine tablets containing 2%, 4% and 8% of carboxymethyl starch sodium respectively, weighing, placing into a measuring flask, adding the diluent to 75% of the volume of the measuring flask, carrying out ultrasonic treatment for 10-20 minutes, shaking for 10-20 minutes, adding the diluent to dilute to the measuring flask scale, shaking uniformly, swirling, centrifuging at 10000rpm for 10 minutes, and taking supernatant to obtain a sample solution;
and (3) respectively injecting the blank solution, the reference substance solution and the sample solution into a high performance liquid chromatograph, and recording a chromatogram to obtain the recovery rate of the carboxymethyl starch sodium.
Preferably, in high performance liquid chromatography, an evaporative light scattering detector, an electric fog detector or a differential shading detector is adopted for detection, so that a chromatogram is obtained.
Preferably, in high performance liquid chromatography, the liquid chromatography is performed,
gel chromatographic column: PL-Aquagel OH 20.5X100 mm,
mobile phase: a solution of methanol-ammonium formate in water,
flow rate: 0.3 to 1.0ml/min,
column temperature: 20-50 ℃,
sample injection amount: 1 to 100 mu L.
Preferably, the diluent is 0.01-5 mol/L sodium hydroxide solution,
compared with the prior art, the method for measuring the content of the carboxymethyl starch sodium in the lamivudine tablet has the following beneficial effects:
1. the content determination method has good specificity, and no interference exists in the lamivudine tablet as a test sample;
2. the sensitivity is good, and the quantitative limit is as low as 1 mug;
3. the accuracy is high, the recovery rate measured by the method is 97.3-102.9%, and the RSD is 2.0%.
Drawings
FIG. 1 is a chromatogram of a blank solution of step (1) according to an embodiment of the invention;
FIG. 2 is a chromatogram of the control solution of step (1) according to an embodiment of the invention;
FIG. 3 is a chromatogram of a test solution of step (4) according to an embodiment of the present invention.
Detailed Description
The following detailed description of embodiments of the invention is, therefore, to be taken in conjunction with the accompanying drawings, and it is to be understood that the scope of the invention is not limited to the specific embodiments.
Throughout the specification and claims, unless explicitly stated otherwise, the term "comprise" or variations thereof such as "comprises" or "comprising", etc. will be understood to include the stated element or component without excluding other elements or components.
According to the method for measuring the content of carboxymethyl starch sodium in the lamivudine tablet, chromatographic separation is adopted, and Evaporative Light Scattering Detector (ELSD), electric fog detector (CAD) or differential shading detector (RI) is adopted for detection, so that a detection method with good specificity, high sensitivity and simple sample preparation is established. Sodium carboxymethyl starch is widely used as a disintegrating agent of capsules and tablets in oral pharmaceutical preparations, achieves rapid and remarkable swelling through rapid water absorption, plays a role in disintegration, has compressibility, can improve the formability of the tablets, increases the hardness of the tablets without affecting the disintegrability, and is a key auxiliary material in preparation development, wherein the general dosage is 2% -8%.
The method for measuring the content of carboxymethyl starch sodium in lamivudine tablet adopts a mass detector for detection and adopts an external standard method for quantification, and specifically comprises the following steps:
(1) Specificity test of carboxymethyl starch sodium by chromatographic separation method
Selecting a gel chromatographic column: PL-Aquagel OH 20 7.5X100 mm
Mobile phase: methanol-10 mM ammonium formate solution (10:90, v/v)
Flow rate: 1.0ml/min
Column temperature: 35 DEG C
Sample injection amount: 3 mu L
A detector: electric fog detector (CAD)
Preparing a solution:
blank solution: 0.1mol/L sodium hydroxide solution
Control solution: precisely weighing a proper amount of carboxymethyl starch sodium, adding a diluent of 0.1mol/L sodium hydroxide solution to 75% of the volume of a measuring flask, carrying out ultrasonic treatment for 1 hour, cooling to room temperature, and diluting with the diluent to prepare a solution containing about 0.2mg/mL of carboxymethyl starch sodium.
The measuring method comprises the following steps:
3 mu L of each of the blank solution and the reference solution is precisely measured, the blank solution and the reference solution are injected into a high performance liquid chromatograph, an electric fog detector is used for detection, and chromatograms are recorded, as shown in fig. 1 and 2, the blank solution has no interference at the peak of carboxymethyl starch sodium, and the method specificity is good.
(2) Linear test of sodium carboxymethyl starch
Selecting a gel chromatographic column: PL-Aquagel OH 20 7.5X100 mm
Mobile phase: methanol-100 mM ammonium formate solution (8:92, v/v)
Flow rate: 1.5ml/min
Column temperature: 25 DEG C
Sample injection amount: 20 μl of
A detector: electric fog type detector
Preparing a solution:
linear solution: precisely weighing a proper amount of carboxymethyl starch sodium, adding a diluent of 0.01mol/L sodium hydroxide solution to 75% of the volume of a measuring flask, carrying out ultrasonic treatment for 1 hour, cooling to room temperature, and diluting with the diluent to prepare solutions respectively containing about 0.1mg/ml, 0.2mg/ml, 0.4mg/ml, 0.8mg/ml and 1.0mg/ml of carboxymethyl starch sodium.
The measuring method comprises the following steps:
and precisely measuring 20 mu l of each linear solution with different concentrations, injecting into a high performance liquid chromatograph, detecting by an electric fog detector, and recording a chromatogram. Regression equations were calculated from the carboxymethyl starch sodium concentration and the corresponding peak area in the series of linear solutions, and the results are shown in the linear test results of table 1.
TABLE 1 Linear test results
| Numbering device | 1 | 2 | 3 | 4 | 5 |
| Concentration x (mg/ml) | 0.11 | 0.23 | 0.42 | 0.83 | 1.02 |
| Peak area y | 3.174 | 6.257 | 12.834 | 25.193 | 30.281 |
The results show that: the linear equation of the carboxymethyl starch sodium is y= 30.242x-0.239, the linear correlation coefficient is 0.999, and the linear relation is good.
The absolute amount (mg) into the liquid phase is: concentration x sample volume, the minimum concentration of the linear solution is 0.1mg/ml, the minimum sample volume is 3 μl, and the absolute amount is 0.1mg/ml, 3 μl=0.3 μg. When the absolute amount is 0.3 μg, the solution concentration can be 0.3 μg/100 μl=0.003 mg/ml when the sample injection volume is adjusted to 100 μl, but the concentration is increased to 0.01mg/ml in consideration of the difference of different instrument responses, and the absolute amount=0.01 mg/ml is 100 μl=1 μg as a quantitative limit, and the quantitative limit is as low as 1 μg.
(3) Accuracy test
Selecting a gel chromatographic column: PL-Aquagel OH 20 7.5X100 mm
Mobile phase: methanol-80 mM ammonium formate solution (10:90, v/v)
Flow rate: 1.0ml/min
Column temperature: 40 DEG C
Sample injection amount: 100 μl of
A detector: electric fog type detector
Preparing a solution:
blank solution: 5mol/L sodium hydroxide solution.
Control solution: precisely weighing a proper amount of carboxymethyl starch sodium, adding a diluent of 0.01mol/L sodium hydroxide solution to 75% of the volume of a measuring flask, carrying out ultrasonic treatment for 1 hour, cooling to room temperature, and diluting with the diluent to prepare solutions respectively containing about 0.1mg/ml, 0.2mg/ml, 0.4mg/ml, 0.8mg/ml and 1.0mg/ml of carboxymethyl starch sodium.
Accuracy test solution: taking 1 piece of self-made lamivudine tablets containing 2%, 4% and 8% of carboxymethyl starch sodium respectively, weighing, placing into a 20ml measuring flask, adding about 15ml of diluent, carrying out ultrasonic treatment for 15 minutes, shaking for 15 minutes, diluting the diluent to a scale, shaking uniformly, vortex, taking a proper amount of solution, centrifuging at 10000rpm for 10 minutes, and taking supernatant. 3 parts of test sample solutions were prepared in parallel for each content gradient, to give solutions numbered 1 to 9 in Table 2.
The measuring method comprises the following steps:
precisely measuring 3 μl of each of the blank solution, the reference solution and the test solution, injecting into a high performance liquid chromatograph, recording the chromatogram, and detecting the sodium carboxymethyl starch of the test solution with the accuracy shown in Table 2.
TABLE 2 accuracy test solution sodium carboxymethyl starch detection results
The results show that: the recovery rate of carboxymethyl starch sodium is in the range of 97.3-102.9%, and the RSD is 2.0%. The method has high accuracy and can accurately detect the content of the carboxymethyl starch sodium in the sample.
(4) Detection of sodium carboxymethyl starch in lamivudine tablets
Selecting a gel chromatographic column: PL-Aquagel OH 20 7.5X100 mm
Mobile phase: methanol-50 mM ammonium formate solution (10:90, v/v)
Flow rate: 1.0mL/min
Column temperature: 35 DEG C
Sample injection amount: 3 mu L
A detector: electric fog type detector
Preparing a solution:
blank solution: 0.1mol/L sodium hydroxide solution
Control solution: precisely weighing a proper amount of carboxymethyl starch sodium, adding a diluent of 0.1mol/L sodium hydroxide solution to 75% of the volume of a measuring flask, carrying out ultrasonic treatment for 1 hour, cooling to room temperature, and diluting with the diluent to prepare solutions respectively containing about 0.1mg/ml, 0.2mg/ml, 0.4mg/ml, 0.8mg/ml and 1.0mg/ml of carboxymethyl starch sodium.
Test solution: taking lamivudine tablet 1, weighing, placing into a 20ml measuring flask, adding about 15ml of diluent, carrying out ultrasonic treatment for 15 minutes, shaking for 15 minutes, diluting the diluent to a scale, shaking uniformly, swirling, taking a proper amount of solution, centrifuging at 10000rpm for 10 minutes, and taking supernatant. (6 parts in parallel, solutions numbered 1 to 6 in Table 3 were obtained)
The measuring method comprises the following steps:
precisely measuring 3 μl of each of blank solution, reference solution and test solution, injecting into high performance liquid chromatograph, recording chromatogram, calculating carboxymethyl starch sodium content in the test according to external standard method, and the results are shown in table 3, and the test solution map is shown in fig. 3.
TABLE 3 detection of sodium carboxymethyl starch content in lamivudine tablets
The foregoing descriptions of specific exemplary embodiments of the present invention are presented for purposes of illustration and description. It is not intended to limit the invention to the precise form disclosed, and obviously many modifications and variations are possible in light of the above teaching. The exemplary embodiments were chosen and described in order to explain the specific principles of the invention and its practical application to thereby enable one skilled in the art to make and utilize the invention in various exemplary embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims and their equivalents.
Claims (4)
1. The method for measuring the content of sodium carboxymethyl starch in lamivudine tablets is characterized by comprising the following steps of:
(1) Taking a linear test of sodium carboxymethyl starch, adding 0.1mol/L sodium hydroxide solution of a diluent into the sodium carboxymethyl starch to 75% of the volume of a measuring flask, carrying out ultrasonic treatment for 1 hour, cooling to room temperature, diluting the solution to a plurality of linear solutions with different concentrations, which contain 0.05-5 mg/ml sodium carboxymethyl starch, by using the diluent, taking the linear solutions with different concentrations of sodium carboxymethyl starch, respectively injecting the linear solutions into a high performance liquid chromatograph, recording a chromatogram, carrying out linear regression on the concentration of sodium carboxymethyl starch and the corresponding peak area, and calculating a standard curve;
in the high performance liquid chromatography:
gel chromatographic column: PL-Aquagel OH 20.5X100 mm,
mobile phase: a solution of methanol-ammonium formate in water,
flow rate: 0.3 to 1.0ml/min,
column temperature: 20-50 ℃,
sample injection amount: 1-100 mu L;
(2) Preparing a sample solution, weighing 1 lamivudine tablet, placing the sample solution into a measuring flask, adding a diluent to 75% of the volume of the measuring flask, performing ultrasonic treatment for 10-20 minutes, shaking for 10-20 minutes, adding the diluent to dilute to the measuring flask scale, shaking uniformly, swirling, centrifuging at 10000rpm for 5-15 minutes, and taking a supernatant to obtain the sample solution;
(3) And (3) detecting sodium carboxymethyl starch in the lamivudine tablet, injecting the sample solution obtained in the step (2) into a high performance liquid chromatograph, recording a chromatogram, and calculating the content of sodium carboxymethyl starch in the sample according to a standard curve method by utilizing the linear equation obtained in the step (1).
2. The method for determining the sodium carboxymethyl starch content in lamivudine tablet according to claim 1, wherein the step (1) is preceded by the steps of:
(0) Preparing a sodium carboxymethyl starch sodium exclusive test, preparing a blank solution of 0.1mol/L sodium hydroxide solution, preparing a reference substance solution, adding a diluent into the sodium carboxymethyl starch to 75% of the volume of a measuring flask, performing ultrasonic treatment for 1-1.5 hours, diluting the sodium carboxymethyl starch sodium into the reference substance solution containing 0.2mg/mL sodium carboxymethyl starch by using the diluent, taking the blank solution and the reference substance solution, injecting the blank solution and the reference substance solution into a high performance liquid chromatograph, recording a chromatogram, and judging the specificity of the sodium carboxymethyl starch content measuring method in the lamivudine tablet according to whether the blank solution has interference at the peak of sodium carboxymethyl starch.
3. The method for determining the sodium carboxymethyl starch content in lamivudine tablet according to claim 1, wherein the step (3) is followed by the steps of:
(4) In the test of the accuracy of the test piece,
preparing a blank solution of 5mol/L sodium hydroxide solution,
preparing a reference substance solution: adding diluent into sodium carboxymethyl starch to 75% of the volume of a measuring flask, carrying out ultrasonic treatment for 1-1.5 hours, cooling to room temperature, diluting with the diluent to obtain a plurality of linear reference substance solutions with different concentrations of 0.05-5 mg/ml sodium carboxymethyl starch,
preparing a test solution: taking 1 piece of self-made lamivudine tablets containing 2%, 4% and 8% of carboxymethyl starch sodium respectively, weighing, placing into a measuring flask, adding the diluent to 75% of the volume of the measuring flask, carrying out ultrasonic treatment for 10-20 minutes, shaking for 10-20 minutes, adding the diluent to dilute to the measuring flask scale, shaking uniformly, swirling, centrifuging at 10000rpm for 10 minutes, and taking supernatant to obtain a sample solution;
and (3) respectively injecting the blank solution, the reference substance solution and the sample solution into a high performance liquid chromatograph, and recording a chromatogram to obtain the recovery rate of the carboxymethyl starch sodium.
4. The method for measuring the sodium carboxymethyl starch content in lamivudine according to claim 1, wherein the high performance liquid chromatography is performed by an evaporative light scattering detector, an electro-fog detector or a differential shading detector to obtain a chromatogram.
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| WO2019199132A1 (en) * | 2018-04-13 | 2019-10-17 | 주식회사 삼양바이오팜 | Lenalidomide oral tablet composition in various amounts |
| CN113030307A (en) * | 2021-03-02 | 2021-06-25 | 天地恒一制药股份有限公司 | Method for determining content of auxiliary materials in lamivudine tablet |
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| WO2019199132A1 (en) * | 2018-04-13 | 2019-10-17 | 주식회사 삼양바이오팜 | Lenalidomide oral tablet composition in various amounts |
| CN113030307A (en) * | 2021-03-02 | 2021-06-25 | 天地恒一制药股份有限公司 | Method for determining content of auxiliary materials in lamivudine tablet |
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| 使用Agilent 1260 Infinity 多检测器 GPC/SEC 系统在不同盐浓度流动相下 对羧甲基淀粉钠进行分析;左夏龙;安捷伦科技（中国）有限公司 应用报告;第3页 * |
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