Analysis method of Sucralfate suspension
1.1 To lay down a procedure for analysis of Sucralfate Suspension.
2.1 This procedure is applicable to the analysis of Sucralfate Suspension.
3.1 Q.C- Chemist
4.1 Manager-Quality Assurance
5.1 Description: Pour 50 ml finish sample in beaker and observed visually.
5.2 pH: Taken 50 ml sample in beaker rinse the pH electrode first with purified water followed by sample dip the electrode in sample and observed the pH.
5.3 Volume variation: Measured the volume by measuring cylinder and determine the volume variation.
5.4.1 In the assay, the principle peak in the chromatogram obtain with the test solution correspond to the peak in the chromatogram obtained with the reference solution.
Each 5ml contains:
Sucralfate USP 1000mg.
Method of Sucralfate suspension.
Mobile phase: Dissolve 132 gm. Of Ammonium sulfate in 900ml of water, dilute with water
To 100ml and mix, Adjust to pH 3.5 with phosphoric acid
Standard preparation: Dissolve an accurately weighed quantity of Potassium Sucrose Octasulphate 10 mg. per ml
Sample preparation: weight accurately about 450mg.of Sucralfate to a 35 ml Centrifuge tube and shake. Add 10 ml of a mixture of 4.0 N Sulphuric Acid and 2.2 N Sodium hydroxide (1:1) sonicate with 5 minute. Keeping the mixture below 300. Add an accurately measured volume in ml 0.1 N sodium hydroxide to bring the pH. of the solution to approximately 2.0 and diltute the solution 15 ml of water. Shake for 1 minute. And centrifuge for 5 minute. If the ph. Is not between 2.3 and 3.5 repeat the test using different volume of 0.1 N sodium hydroxide.
The liquid chromatography with a Refractive index detector and a 3.9 mm x 30-cm column that containing packing L8. the detector and column temperature are maintened.at 300. Injection volume 50 µl.
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|1.0||STP||Standard Testing Procedure|
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