Analysis method of Sucralfate suspension
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Sucralfate Suspension.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Sucralfate Suspension.
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Manager-Quality Assurance
5.0 Procedure
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 Identification:
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.
5.5 ASSAY:
Each 5ml contains:
Sucralfate USP 1000mg.
Method of Sucralfate suspension.
By HPLC
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
With mobile.
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.
Chromatographic condition:
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.
Calculation:
6.0 Abbreviation
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1.0 | STP | Standard Testing Procedure |
| 2.0 | QA | Quality assurance |
| 3.0 | STD | Standard |
| 4.0 | SPL | Sample |
| 5.0 | NM | Nano Meter |
7.0 (ANNEXURE)
NA
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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