Analysis method of Piracetam Syrup
1.1 To lay down a procedure for analysis of Piracetam Syrup.
2.1 This procedure is applicable to the analysis of Piracetam 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:
Piracetam IP 500mg
Estimation of Piracetam Syrup:
Method of Piracetam Syrup:
Method: BY HPLC
Buffer: Weight 50 mg dipotassium hydrogen orthophosphate diluted to 500 ml water adjust to ph-6.0 with orthophosphoric acid.
Mobile phase: Buffer : Acetonitrile
90 : 10
Solvent mixture: Water : Acetonitrile
90 : 10
Standard preparation: Weight 50 mg of Piracetam diluted to 100 ml volumetric flask with solvent mixture.
Sample preparation: Weight accurately equivalent to 50 mg. of piracetam diluted to 100 ml volumetric flask with solvent mixture.
Flow rate – 1.5 ml /mint.
Column -c18 (4.6 x250 mm) 5 µm.
Temperature -Ambient Temp.
Injection volume – 20µl.
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|1.0||STP||Standard Testing Procedure.|
7.0 ATTACHMENTS (ANNEXES)
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