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Method for separating and determining levocetirizine hydrochloride and enantiomer thereof through HPLC method

A technology of levocetirizine hydrochloride and enantiomer, which is applied in the field of analytical chemistry, can solve the problems of heavy taste, short service life, high toxicity and the like of normal phase chromatography, and achieves excellent separation performance and durability, Good separation and low toxicity

Active Publication Date: 2016-09-21
CHONGQING HUABANGSHENGKAI PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this patent, the first chromatographic column packing is α 1 -Acid glycoprotein, the service life is not long, it is easy to break
Secondly, the patented method is reported as normal phase chromatography, which has a strong taste and high toxicity
At present, there is no public method report that uses β-cyclodextrin silica gel as a filler, is durable, environmentally friendly, has low toxicity, and can also rapidly separate levocetirizine hydrochloride and its enantiomers

Method used

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  • Method for separating and determining levocetirizine hydrochloride and enantiomer thereof through HPLC method
  • Method for separating and determining levocetirizine hydrochloride and enantiomer thereof through HPLC method
  • Method for separating and determining levocetirizine hydrochloride and enantiomer thereof through HPLC method

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Experimental program
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Effect test

Embodiment 1

[0060] Embodiment 1 Separation and determination of levocetirizine hydrochloride and its enantiomer

[0061] Preparation of enantiomer solution: take about 25 mg of enantiomer reference substance, put it in a 100ml measuring bottle, add diluent to dissolve and dilute to the mark, shake well, and obtain enantiomer stock solution. Precisely pipette 0.5ml of the above solution, put it in a 100ml measuring bottle, add a diluent to dilute to the mark, and shake well to obtain a reference solution with an enantiomer concentration of 1.25 μg / ml.

[0062] Preparation of mixed solution: Weigh about 25 mg of levocetirizine hydrochloride, put it in a 100ml measuring bottle, accurately pipette 0.5ml of enantiomer stock solution, put it in the same measuring bottle as above, add diluent to dissolve and dilute to the mark , shake well, and serve.

[0063] The diluent and the mixed solution were respectively injected according to the above-mentioned chromatographic conditions, and the chrom...

Embodiment 2

[0081] Example 2 Basic research on detection limit and quantitative limit of levocetirizine hydrochloride and enantiomers by chromatographic system

[0082] Limit of quantitation solution: accurately weigh levocetirizine hydrochloride and enantiomer reference substance, make a solution with a certain concentration, and dilute step by step to obtain a limit of quantitation solution, as shown in Table 2.

[0083] Detection limit solution: accurately pipette 7.0ml of the quantification limit solution, put it in a 20ml measuring bottle, add diluent to dilute to the mark, shake well, and obtain the detection limit solution, as shown in Table 3.

[0084] test methods:

[0085] The above quantification limit solution was continuously injected 3 times, and the detection limit solution was continuously injected 2 times, and the ratio of the main peak height to noise (signal-to-noise ratio) was calculated. Record the chromatogram, and the test results are shown in Table 4 and Table 5. ...

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Abstract

The invention belongs to the field of analytical chemistry, and particularly relates to a method for separating and determining levocetirizine hydrochloride and enantiomer thereof through an HPLC method. In the method, an adopted chromatographic column takes silica gel of which the surface is chemically bonded with beta-cyclodextrin as filler, elution is conducted through a mobile phase A and a mobile phase B, and detection is conducted by entering a detector; the mobile phase A is an inorganic salt buffer system, and the mobile phase B is organic solvent. The method is a reversed phase high performance liquid chromatography method, separation and determination of levocetirizine hydrochloride and the enantiomer thereof can be achieved simultaneously, excellent separation performance and durability are achieved, the method is simple, convenient, feasible, good in reproducibility, efficient and rapid, the analysis time is significantly shortened, the tailing factor and theoretical pedal number can both reach very good effects, the content of the enantiomer in levocetirizine hydrochloride can be effectively determined, and specificity is high.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for separating and measuring levocetirizine hydrochloride and its enantiomers by HPLC. Background technique [0002] Levocetirizine Hydrochloride (Levocetirizine Hydrochloride), listed in February 2001, is a third-generation antihistamine and a single optical isomer of the second-generation antihistamine cetirizine (cetirizine TP -isomer), developed by UCB, is a selective histamine H1 receptor antagonist, has no obvious anticholinergic and anti-serotonin effects, and has a small central inhibitory effect, and is mainly used for the treatment of respiratory system, skin and Allergic diseases of the eyes, such as allergic rhinoconjunctivitis, allergic skin diseases, allergic asthma, etc., have the advantages of quick onset of action, strong and long-lasting effect and few side effects. [0003] Levocetirizine hydrochloride is applicable to a wide range of p...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 林晓兵张波
Owner CHONGQING HUABANGSHENGKAI PHARM
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