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HPLC (high performance liquid chromatography) Detection method of ketorolac tromethamine or ketorolac tromethamine or/and impurities in ketorolac tromethamine preparation

A technology of ketorolac tromethamine and a detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as damage to detection instruments, and achieve reduced damage, guaranteed detection and separation, and good impurity detection capabilities Effect

Active Publication Date: 2018-06-12
CHENGDU BRILLIANT PHARMA CO LTD
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Problems solved by technology

[0004] In USP and EP Pharmacopoeia, there are following deficiencies in the liquid chromatographic detection of KTT crude drug impurities: mobile phase salt phase is ammonium dihydrogen phosphate (regulate pH to 3.0 with phosphoric acid), organic phase is tetrahydrofuran, and Tetrahydrofuran will cause certain damage to the detection instrument

Method used

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  • HPLC (high performance liquid chromatography) Detection method of ketorolac tromethamine or ketorolac tromethamine or/and impurities in ketorolac tromethamine preparation
  • HPLC (high performance liquid chromatography) Detection method of ketorolac tromethamine or ketorolac tromethamine or/and impurities in ketorolac tromethamine preparation
  • HPLC (high performance liquid chromatography) Detection method of ketorolac tromethamine or ketorolac tromethamine or/and impurities in ketorolac tromethamine preparation

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Embodiment Construction

[0053] The chromatographic instrument used in the present invention is an Agilent 1260 high performance liquid chromatograph.

[0054] See Table 1 for the control limits of impurities in ketorolac tromethamine (KTT) and its injection and the prior art detection conditions of each impurity.

[0055] Table 1

[0056]

[0057] Wherein, impurity A, B, C, D are obtained by purchasing, impurity E (referring to patent U.S., 5621115) and impurity F (referring to "Kaneria, Ankur et al, Fe-EROS Encyclopedia of Reagents for Organic Synthesis, Triethyl Methanetricarboxylate, 2001" ) were synthesized by the laboratory respectively.

[0058] The HPLC detection method of impurity or / and ketorolac tromethamine in the injection liquid of the present invention and preparation thereof especially is as follows:

[0059] (1) Chromatographic conditions

[0060] Chromatographic column: ZORBAX Eclipse plus C8 column, size 4.6×250mm, 5μm, column temperature 40°C;

[0061] Detector: UV detector, d...

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Abstract

The invention discloses an HPLC (high performance liquid chromatography) detection method of ketorolac tromethamine or ketorolac tromethamine or / and impurities in ketorolac tromethamine preparation; HPLC is used to detect a solution under detection, and qualitatively or quantitatively determining according to chromatographic results. The HPLC impurity detection method for ketorolac tromethamine bulk pharmaceutical chemicals and related impurities in injections has the advantages that optimizing and modifying are performed in the aspects of detection wavelength and mobile phase system determining, test solution concentration screening and the like, the method is verified in the aspects of system applicability, degrading specificity, detection limit and quantitative limit, linearity and range, precision, accuracy, solution stability, method durability and the like, and the results show that the method has good capacity of detecting impurities.

Description

technical field [0001] The invention belongs to the technical field of substance detection, in particular to an HPLC detection method for ketorolac tromethamine or / and impurities in ketorolac tromethamine or its preparation. Background technique [0002] Ketorolac Tromethamine, English name Ketorolac Tromethamine, KTT for short, CAS No. 74103-07-4. Ketorolac tromethamine is a non-steroidal anti-inflammatory drug that can inhibit the biosynthesis of prostaglandins, and its biological activity is related to its S-form. Animal studies have shown that ketorolac tromethamine has analgesic effects, but no sedative or anxiolytic effects. [0003] According to the KTT synthesis route, it can be seen that the impurities that may appear are mainly degradation impurities. For example, the reaction between ketorolac and tromethamine produces impurity A (CAS No. 167105-80-8), and ketorolac is oxidized during the synthesis process to form impurities B (CAS No. 154476-25-2, 1-hydroxyketo...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 陈礼莉徐彦王丽涛陈垌辉
Owner CHENGDU BRILLIANT PHARMA CO LTD
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