雷贝拉唑钠标准-印度药典 IP2010
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Βιβλιοθήκη Baidu
Identification
A. Determine by infrared absorption spectrophotometry (2.4.6). Compare the spectrum with that obtained with rabeprazole sodium RS.
B. A 10 per cent w/v solution in carbon dioxide-free water gives reaction ofsodium (2.3.1).
Rabeprazole Tablets
Rabeprazole Sodium Tablets
Rabeprazole Tablets contain not less than 90.0 per cent and not more than 110.0 per cent of the stated amount of rabeprazole sodium, ClsHzoN303SNa. The tablets are enteric coated. Usual strength. 20 mg.
IP 2010
RABEPRAZOLE TABLETS
Rabeprazole Sodium
Heavy metals (2.3.13). 1.0 g complies with the limit test for heavy metals, Method B (20 ppm). Water (2.3.43). Not more than 7.0 per cent, determined on 0.3 g, Assay. Determine by liquid chromatography (2.4.14).
Chromatographic system as described under Assay. Inject reference solution (b). The test is not valid unless the tailing factor is not more than 2.0 and the column efficiency in not less than 2000 theoretical plates. Inject the test solution and reference solution (b). Run the chromatogram three times of the principal peale In the chromatogram obtained with the test solution, the area ofany secondary peak is not more than 0.5 times the area ofthe peak in the chromatogram obtained with reference solution (b) (0.5 per cent) and the sum of areas of all the secondary peaks is not more than 1.5 times the area ofthe peak in the chromatogram obtained with the reference solution (b) (1.5 per cent).
Tests
Dissolution (2.5.2). Apparatus No.1, Medium. 900 ml of 0.1 M hydrochloric acid,
2037
RABEPRAZOLE TABLETS Speed and time. 50 rpm and 120 minutes. Replace the 0.1 M hydrochloric acid with phosphate buffer pH 7.4. Run the apparatus at 75 ipm for 45 minutes. Withdraw a suitable volume of the medium and filter. Measure the absorbance ofthe filtered solution immediately, suitably diluted with the dissolution medium, ifnecessary, at the maximum at about 291 nm (2.4.7). Calculate the content ofCIsHzoN303SNa in the medium from the absorbance obtained from a solution of known concentration of rabeprazole sodium RS, prepared by dissolving in minimum quantity ofa mixture of?5 volumes of acetonitrile and 25 volumes of methanol and suitably diluted with the dissolution medium. D. Not less than 70 per cent of the stated amount of ClsHzoN303SNa. Related substances. Determine by liquid chromatography (2.4.14).
Test solution. Dissolve 0.1 g of the substance under examination in 100.0 ml ofsolvent mixture. Dilute 5.0 ml ofthe solution to 100.0 ml with the same solvent. Reference solution. A 0.005 per cent w/v solution of rabeprazole sodium RS in the solvent mixture.
Tests
Related substances. Determine by liquid chromatography (2.4.14).
Solvent mixture. 80 volumes of methanol, 20 volumes of water and 0.1 volume of diethylamine. Test solution. Dissolve 50 mg of the substance under examination in 100 ml with the solvent mixture. Reference solution (a). A 0.05 per cent w/v solution of rabeprazole sodium RS in the solvent mixture. Reference solution (b). Dilute 1 ml ofreference solution (a) to 100 ml with solvent mixture.
Chromatographic system a stainless steel column 25 cm ' 4.6 mm packed with octadecylsilane bonded to porous silica (5 /lm), mobile phase: a mixture of65 volumes of 0.15 per cent w/v solution of potassium dihydrogen phosphate previously adjusted pH to 6.0 with orthophosphoric acid or sodium hydroxide solution and 35 volumes of acetonitrile, flow rate. 1 ml per minute, spectrophotometer set at 280 nm, injection volume. 10 /ll. Inject the reference solution. The test is not valid unless the tailing factor is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 per cent. Inject the test solution and the reference solution. Calculate the content ofClsHzoN303SNa. Storage. Store protected from light and moisture.
IP2010
Solvent mixture. 80 volumes of methanol, 20 volumes of water and 0.1 volume of diethylamine. Test solution. Weigh and powder 20 tablets. Weigh accurately a quantity of the powdered tablet containing 50 mg of Rabeprazole Sodium, disperse in 20 ml of 0.1 M sodium hydroxide and dilute to 100.0 ml with solvent mixture, filter. Reference solution. Weigh accurately about 25 mg of rabeprazole sodium RS, dissolve in 10 ml of 0.1 M sodium hydroxide and dilute to 50.0 ml with solvent mixture.
Solvent mixture. 80 volumes of methanol, 20 volumes of water and 0.1 volume of diethylamine.
Mol. Wt. 381.4 Rabeprazole sodium is 2-( {[4-(3-methoxypropoxy)-3-methyl2-pyridinyl]methyl} sulphinyl)-IH-benzimidazole sodium. Rabeprazole sodium contains not less than 98.0 per cent and not more than 102.0 per cent ofClsHzoN303S,Na, calculated on the anhydrous basis. Category. Antiulcer. Description. A white to light yellow, crystalline powder, hygroscopic.
Identification
In the Assay, the principal peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution.
Chromatographic system - a stainless steel column 25 cm x 4.6 mm packed with octylsilane bonded to porous silica (5 !!m) (Such as Hypersil keystone betabasic C s), - column temperature 40°, mobile phase: a mixture of 72 volumes of 0.1 M phosphate buffer pH 7.0 and 28 volumes of acetonitrile, - flow rate. 1.4 ml per minute, - spectrophotometer set at 282 nm, - injection volume. 10 !!l. Inject the reference solution. The test is not valid unless the tailing factor is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 per cent. Inject the test solution and the reference solution. Calculate the percentage content ofClsHzoN303S,Na. Storage. Store protected from light and moisture.
Identification
A. Determine by infrared absorption spectrophotometry (2.4.6). Compare the spectrum with that obtained with rabeprazole sodium RS.
B. A 10 per cent w/v solution in carbon dioxide-free water gives reaction ofsodium (2.3.1).
Rabeprazole Tablets
Rabeprazole Sodium Tablets
Rabeprazole Tablets contain not less than 90.0 per cent and not more than 110.0 per cent of the stated amount of rabeprazole sodium, ClsHzoN303SNa. The tablets are enteric coated. Usual strength. 20 mg.
IP 2010
RABEPRAZOLE TABLETS
Rabeprazole Sodium
Heavy metals (2.3.13). 1.0 g complies with the limit test for heavy metals, Method B (20 ppm). Water (2.3.43). Not more than 7.0 per cent, determined on 0.3 g, Assay. Determine by liquid chromatography (2.4.14).
Chromatographic system as described under Assay. Inject reference solution (b). The test is not valid unless the tailing factor is not more than 2.0 and the column efficiency in not less than 2000 theoretical plates. Inject the test solution and reference solution (b). Run the chromatogram three times of the principal peale In the chromatogram obtained with the test solution, the area ofany secondary peak is not more than 0.5 times the area ofthe peak in the chromatogram obtained with reference solution (b) (0.5 per cent) and the sum of areas of all the secondary peaks is not more than 1.5 times the area ofthe peak in the chromatogram obtained with the reference solution (b) (1.5 per cent).
Tests
Dissolution (2.5.2). Apparatus No.1, Medium. 900 ml of 0.1 M hydrochloric acid,
2037
RABEPRAZOLE TABLETS Speed and time. 50 rpm and 120 minutes. Replace the 0.1 M hydrochloric acid with phosphate buffer pH 7.4. Run the apparatus at 75 ipm for 45 minutes. Withdraw a suitable volume of the medium and filter. Measure the absorbance ofthe filtered solution immediately, suitably diluted with the dissolution medium, ifnecessary, at the maximum at about 291 nm (2.4.7). Calculate the content ofCIsHzoN303SNa in the medium from the absorbance obtained from a solution of known concentration of rabeprazole sodium RS, prepared by dissolving in minimum quantity ofa mixture of?5 volumes of acetonitrile and 25 volumes of methanol and suitably diluted with the dissolution medium. D. Not less than 70 per cent of the stated amount of ClsHzoN303SNa. Related substances. Determine by liquid chromatography (2.4.14).
Test solution. Dissolve 0.1 g of the substance under examination in 100.0 ml ofsolvent mixture. Dilute 5.0 ml ofthe solution to 100.0 ml with the same solvent. Reference solution. A 0.005 per cent w/v solution of rabeprazole sodium RS in the solvent mixture.
Tests
Related substances. Determine by liquid chromatography (2.4.14).
Solvent mixture. 80 volumes of methanol, 20 volumes of water and 0.1 volume of diethylamine. Test solution. Dissolve 50 mg of the substance under examination in 100 ml with the solvent mixture. Reference solution (a). A 0.05 per cent w/v solution of rabeprazole sodium RS in the solvent mixture. Reference solution (b). Dilute 1 ml ofreference solution (a) to 100 ml with solvent mixture.
Chromatographic system a stainless steel column 25 cm ' 4.6 mm packed with octadecylsilane bonded to porous silica (5 /lm), mobile phase: a mixture of65 volumes of 0.15 per cent w/v solution of potassium dihydrogen phosphate previously adjusted pH to 6.0 with orthophosphoric acid or sodium hydroxide solution and 35 volumes of acetonitrile, flow rate. 1 ml per minute, spectrophotometer set at 280 nm, injection volume. 10 /ll. Inject the reference solution. The test is not valid unless the tailing factor is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 per cent. Inject the test solution and the reference solution. Calculate the content ofClsHzoN303SNa. Storage. Store protected from light and moisture.
IP2010
Solvent mixture. 80 volumes of methanol, 20 volumes of water and 0.1 volume of diethylamine. Test solution. Weigh and powder 20 tablets. Weigh accurately a quantity of the powdered tablet containing 50 mg of Rabeprazole Sodium, disperse in 20 ml of 0.1 M sodium hydroxide and dilute to 100.0 ml with solvent mixture, filter. Reference solution. Weigh accurately about 25 mg of rabeprazole sodium RS, dissolve in 10 ml of 0.1 M sodium hydroxide and dilute to 50.0 ml with solvent mixture.
Solvent mixture. 80 volumes of methanol, 20 volumes of water and 0.1 volume of diethylamine.
Mol. Wt. 381.4 Rabeprazole sodium is 2-( {[4-(3-methoxypropoxy)-3-methyl2-pyridinyl]methyl} sulphinyl)-IH-benzimidazole sodium. Rabeprazole sodium contains not less than 98.0 per cent and not more than 102.0 per cent ofClsHzoN303S,Na, calculated on the anhydrous basis. Category. Antiulcer. Description. A white to light yellow, crystalline powder, hygroscopic.
Identification
In the Assay, the principal peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution.
Chromatographic system - a stainless steel column 25 cm x 4.6 mm packed with octylsilane bonded to porous silica (5 !!m) (Such as Hypersil keystone betabasic C s), - column temperature 40°, mobile phase: a mixture of 72 volumes of 0.1 M phosphate buffer pH 7.0 and 28 volumes of acetonitrile, - flow rate. 1.4 ml per minute, - spectrophotometer set at 282 nm, - injection volume. 10 !!l. Inject the reference solution. The test is not valid unless the tailing factor is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 per cent. Inject the test solution and the reference solution. Calculate the percentage content ofClsHzoN303S,Na. Storage. Store protected from light and moisture.