Analysis method of Levetiracetam Syrup
1.1 To lay down a procedure for analysis of Levetiracetam Syrup.
2.1 This procedure is applicable to the analysis of Levetiracetam Syrup quality control laboratory,
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 1.0 ml contains:
Levetiracetam IP 100mg.
Estimation of Levetiracetam Syrup:
Method of Levetiracetam Syrup:
Method: BY HPLC
Buffer: 1.0 ml Orthophoshoric Acid diluted to 1000 ml water
Mobile phase: Buffer : Acetonitrile
40 : 60
Standard preparation: Weight 100 mg of Levetiracetam diluted to 100 ml volumetric flask with mobile phase.
Sample preparation: Taken 1.0 ml sample diluted to 100 ml volumetric flask with Mobile phase.
Flow rate – 1.5 ml /mint.
column -C18 (150mm x4.6) 5µm.
Temperature -Ambient Temp.
Injection Volume -20µl.
|Sr. No.||Abbreviation used.||Full form of abbreviation used.|
|1.0||STP||Standard Testing Procedure.|
7.0 ATTACHMENTS (ANNEXES)
|Sr. No.||Reference Title|