Esomeprazole sodium and method for detecting impurity content in esomeprazole sodium for injection

Abstract

The invention provides esomeprazole sodium and a method for detecting content of the esomeprazole sodium for injection. A chromatographic column, using octadecyl silane bonded silica gel or octo-alkyl silane bonded silica gel as a filling agent, implements the gradient elution with mixed solvent of an organic phase and a water phase as a mobile phase to measure the esomeprazole sodium and the content of eight impurities thereof. The method is simple in process and low in cost, and adopts the gradient elution method to measure the esomeprazole sodium and the content of eight important impurities thereof; the detection method is scientific, reasonable and objective, so that the quality of the esomeprazole sodium can be preferably controlled.

Description

technical field

[0001] The invention belongs to the field of drug analysis, in particular to a method for detecting impurity content in proton pump inhibitor esomeprazole sodium and esomeprazole sodium for injection. Background technique

[0002] Esomeprazole sodium (Esomeprazole Sodium, S-5-methoxy-2{[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl}-1H -benzimidazole sodium) is a powerful free radical scavenger and antioxidant, its molecular formula is C 17 h 12 N 3 NaO 3 S, molecular weight 367.4, structural formula:

[0003]

[0004] Esomeprazole sodium is the drug of choice for the treatment of acid-related diseases such as peptic ulcer and gastroesophageal reflux disease. As a single isomer of omeprazole, that is, (S)-isomer, it has higher bioavailability and more consistent pharmacokinetics, which increases the drug reaching the proton pump, and its acid suppression effect is better than that of Other proton pump inhibitors (PPIs).

[0005] Esomeprazole sod...

Examples

Embodiment 1

[0026] Embodiment 1 Determination of impurities in esomeprazole sodium by high performance liquid chromatography

[0027] Determination according to high performance liquid phase method (Chinese Pharmacopoeia 2010 edition two appendix V D)

[0028] Chromatographic conditions and system suitability test Octadecylsilane bonded silica gel was used as filler. Mobile phase: mobile phase A is an aqueous solution containing 1.4 g of disodium hydrogen phosphate dodecahydrate per 1 L, adjusted pH to 7.4 with phosphoric acid, mobile phase B is acetonitrile, and performs gradient elution. Take esomeprazole sodium and impurity 4 respectively and dilute with the initial mobile phase to make a mixed solution with a concentration of 0.02mg / ml, as a system suitability solution. Take 10 μl of the system suitability solution and inject it into the liquid chromatograph, the peak order is impurity 4, esomeprazole, and the separation degree of impurity 4 and esomeprazole should meet the requireme...

Embodiment 2

[0036] Embodiment 2 Determination of impurities in esomeprazole sodium by high performance liquid chromatography

[0037] Determination according to high performance liquid phase method (Chinese Pharmacopoeia 2010 edition two appendix V D)

[0038] Chromatographic conditions and system suitability test Octadecylsilane bonded silica gel was used as filler. Mobile phase: mobile phase A is an aqueous solution containing 1.4 g of disodium hydrogen phosphate dodecahydrate per 1 L, adjusted pH to 7.6 with phosphoric acid, mobile phase B is methanol, and gradient elution is performed. Take esomeprazole sodium and impurity 4 respectively and dilute with the initial mobile phase to make a mixed solution with a concentration of 0.02mg / ml, as a system suitability solution. Take 10 μl of the system suitability solution and inject it into the liquid chromatograph, the peak order is impurity 4, esomeprazole, and the separation degree of impurity 4 and esomeprazole should meet the requireme...

Embodiment 3

[0046] Embodiment 3 Determination of impurities in esomeprazole sodium by high performance liquid chromatography

[0047] Determination according to high performance liquid phase method (Chinese Pharmacopoeia 2010 edition two appendix V D)

[0048] Chromatographic conditions and system suitability test Octadecylsilane bonded silica gel was used as filler. Mobile phase: mobile phase A is an aqueous solution containing 1.4 g of disodium hydrogen phosphate dodecahydrate per 1 L, adjusted pH to 7.8 with phosphoric acid, mobile phase B is acetonitrile, and performs gradient elution. Take esomeprazole sodium and impurity 4 respectively and dilute with the initial mobile phase to make a mixed solution with a concentration of 0.02mg / ml, as a system suitability solution. Take 10 μl of the system suitability solution and inject it into the liquid chromatograph, the peak order is impurity 4, esomeprazole, and the separation degree of impurity 4 and esomeprazole should meet the requireme...

technical field

[0001] The invention belongs to the field of drug analysis, in particular to a method for detecting impurity content in proton pump inhibitor esomeprazole sodium and esomeprazole sodium for injection. Background technique

[0002] Esomeprazole sodium (Esomeprazole Sodium, S-5-methoxy-2{[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl}-1H -benzimidazole sodium) is a powerful free radical scavenger and antioxidant, its molecular formula is C 17 h 12 N 3 NaO 3 S, molecular weight 367.4, structural formula:

[0003]

[0004] Esomeprazole sodium is the drug of choice for the treatment of acid-related diseases such as peptic ulcer and gastroesophageal reflux disease. As a single isomer of omeprazole, that is, (S)-isomer, it has higher bioavailability and more consistent pharmacokinetics, which increases the drug reaching the proton pump, and its acid suppression effect is better than that of Other proton pump inhibitors (PPIs).

[0005] Esomeprazole sod...

Examples

Embodiment 1

[0026] Embodiment 1 Determination of impurities in esomeprazole sodium by high performance liquid chromatography

[0027] Determination according to high performance liquid phase method (Chinese Pharmacopoeia 2010 edition two appendix V D)

[0028] Chromatographic conditions and system suitability test Octadecylsilane bonded silica gel was used as filler. Mobile phase: mobile phase A is an aqueous solution containing 1.4 g of disodium hydrogen phosphate dodecahydrate per 1 L, adjusted pH to 7.4 with phosphoric acid, mobile phase B is acetonitrile, and performs gradient elution. Take esomeprazole sodium and impurity 4 respectively and dilute with the initial mobile phase to make a mixed solution with a concentration of 0.02mg / ml, as a system suitability solution. Take 10 μl of the system suitability solution and inject it into the liquid chromatograph, the peak order is impurity 4, esomeprazole, and the separation degree of impurity 4 and esomeprazole should meet the requireme...

Embodiment 2

[0036] Embodiment 2 Determination of impurities in esomeprazole sodium by high performance liquid chromatography

[0037] Determination according to high performance liquid phase method (Chinese Pharmacopoeia 2010 edition two appendix V D)

[0038] Chromatographic conditions and system suitability test Octadecylsilane bonded silica gel was used as filler. Mobile phase: mobile phase A is an aqueous solution containing 1.4 g of disodium hydrogen phosphate dodecahydrate per 1 L, adjusted pH to 7.6 with phosphoric acid, mobile phase B is methanol, and gradient elution is performed. Take esomeprazole sodium and impurity 4 respectively and dilute with the initial mobile phase to make a mixed solution with a concentration of 0.02mg / ml, as a system suitability solution. Take 10 μl of the system suitability solution and inject it into the liquid chromatograph, the peak order is impurity 4, esomeprazole, and the separation degree of impurity 4 and esomeprazole should meet the requireme...

Embodiment 3

[0046] Embodiment 3 Determination of impurities in esomeprazole sodium by high performance liquid chromatography

[0047] Determination according to high performance liquid phase method (Chinese Pharmacopoeia 2010 edition two appendix V D)

[0048] Chromatographic conditions and system suitability test Octadecylsilane bonded silica gel was used as filler. Mobile phase: mobile phase A is an aqueous solution containing 1.4 g of disodium hydrogen phosphate dodecahydrate per 1 L, adjusted pH to 7.8 with phosphoric acid, mobile phase B is acetonitrile, and performs gradient elution. Take esomeprazole sodium and impurity 4 respectively and dilute with the initial mobile phase to make a mixed solution with a concentration of 0.02mg / ml, as a system suitability solution. Take 10 μl of the system suitability solution and inject it into the liquid chromatograph, the peak order is impurity 4, esomeprazole, and the separation degree of impurity 4 and esomeprazole should meet the requireme...

Images