阅读说明：本技术 一种l-丙氨酸异丙酯中对映异构体含量的检测方法 (Method for detecting content of enantiomer in isopropyl L-alanine ) 是由 沙薇 杨苗苗 吕艳歌 于 2018-08-21 设计创作，主要内容包括：本发明属于药物分析领域,具体涉及一种L-丙氨酸异丙酯盐酸盐中对映异构体含量的高效液相色谱检测方法。所述方法包括：照高效液相色谱法测定,用冠醚手性色谱柱,以pH1.0的高氯酸水溶液为流动相。本发明可以有效地分离L-丙氨酸异丙酯盐酸盐及其对映异构体,能够更准确地检测对映异构体的含量。本方法采用反相方法,等度洗脱,简单易操作,且峰形较好,分离度合格；方法学验证显示本方法专属性强,灵敏度高,准确度、耐用性均良好。(The invention belongs to the field of pharmaceutical analysis, and particularly relates to a high performance liquid chromatography detection method for content of an enantiomer in L-alanine isopropyl ester hydrochloride. The method comprises the following steps: performing high performance liquid chromatography, and using crown ether chiral chromatographic column and perchloric acid aqueous solution with pH of 1.0 as mobile phase. The method can effectively separate L-alanine isopropyl ester hydrochloride and the enantiomer thereof, and can more accurately detect the content of the enantiomer. The method adopts a reverse phase method, isocratic elution, is simple and easy to operate, has better peak shape and qualified separation degree; the methodological verification shows that the method has strong specificity, high sensitivity, good accuracy and good durability.)

1. A detection method for detecting L-alanine isopropyl ester hydrochloride and enantiomer thereof is characterized by comprising the following steps:

1) detecting on a high performance liquid chromatograph;

2) adopting a reverse phase separation mode;

3) chromatographic column packing agent: the surface of the silica gel is coated with chiral crown ether;

4) column temperature: 15-25 ℃;

5) flow rate: 0.3mL/min to 0.7 mL/min;

6) detection wavelength: 203nm-207 nm;

7) mobile phase: an acidic aqueous solution;

8) diluting liquid: purifying the water;

9) preparing a system applicability solution: respectively taking appropriate amount of impurity TN-SM2-R2 reference substance, enantiomer reference substance and L-alanine isopropyl ester hydrochloride reference substance, adding purified water for dissolving and diluting to prepare a mixed solution containing 50 mu g of impurity TN-SM2-R2 and enantiomer and 2.5mg of L-alanine isopropyl ester hydrochloride in each 1ml as a system applicability solution;

10) preparing a sample solution: taking a proper amount of the product, precisely weighing, placing into a measuring flask, adding purified water for dissolving, and diluting to prepare a solution containing 5mg per 1 ml;

11) preparing a control solution: a suitable amount of the sample solution was diluted with purified water to prepare a solution containing about 25. mu.g per 1 ml.

2. The method of claim 1, wherein the chromatography column is CROWNPAKCR (+) (4.0 mm x 150mm, 5 μ ι η).

3. The method according to claim 1, wherein the mobile phase is an aqueous solution of perchloric acid having a pH of 1.0 to 2.0, preferably a pH of 1.0.

4. The process according to claim 1, wherein the column temperature is 15 ℃ to 25 ℃, preferably 20 ℃.

5. The method according to claim 1, wherein the flow rate is 0.3-0.7 mL/min, preferably 0.5 mL/min.

6. The method according to claim 1, wherein the wavelength is 203nm-207nm, preferably 205 nm.

7. The method of claim 1, wherein a baseline separation is achieved between peaks in the system suitability solution, with a degree of separation of greater than or equal to 1.5.

8. The method of claim 1, wherein the calculation of the enantiomers is a self-control method.