Analysis method of Salbutamol and Choline theophyllinate Syrup
1.1 To lay down a procedure for analysis of Levosalbutamol and Choline theophyllinate Syrup.
2.1 This procedure is applicable to the analysis of Levosalbutamol & Choline theophyllinate Syrup.quality control laboratories.
3.1 Q.C- Chemist
4.1 Manager-Quality Assurance
5.1 Description: Pour 50ml 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 5.0 ml contains:
Levosulbutamol Sulphate IP
Eq. to Levosulbutamol 1.0 mg.
Choline theophyllinate IP 50 mg.
Estimation of Levosulbutamol Sulphate &Choline theophyllinate Syrup:
Method of Levosulbutamol Sulphate Syrup:
Method: BY HPLC
Buffer: 0.29% w/v of sodium Heptainesulphonate and 0.25%w/v potassium dihydrogen phosphate dihydrate adjust to pH 3.7 With Orthophoshoric Acid.
Mobile phase: Buffer : Acetonitrile
78 : 22
Standard preparation: Weight 50 mg of Levosulbutamol Sulphate diluted to 100 ml volumetric flask with Mobile phase. Further dilution 2 ml to 50 ml volumetric flask with mobile phase.
Sample preparation: Taken accurately equivalent to 2mg. Levosulbutamol Sulphate diluted to 100 ml volumetric flask volumetric flask with Mobile phase.
Flow rate – 1.0 ml /mint.
column -C8 (150mm x3.9) 5µm. (Such as water symmetry C8)
Injection Volume -20µl.
Method of Choline theophyllinate.
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|1.0||STP||Standard Testing Procedure.|
Sr. No. Reference Title
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