Analysis method of Racecadotril suspension
1.1 To lay down a procedure for analysis of Racecadotril suspension.
2.1 This procedure is applicable to the analysis of Racecadotril suspension in QC lab
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 obtained with the reference solution.
Each 5ml contains
Racecadotril I.P. 10 mg
Estimation of Racecadotril suspension:
Method of Racecadotril suspension:
BUFFER: 6.8 gm of potassium dihydrogen orthophosphate acid diluted 1000 ml water. Adjust to ph 3.0 with orthophoshoric acid
Mobile phase: BUFFER: ACN: METHANOL
40 : 40 : 20
Solvent mixture: Equal volume acetonitrile and water.
Standard preparation: Weight accurately about 25mg std. of Rcecadotril diluted to 100 ml volumetric with solvent mixture.
Test preparation: Weight accurately Equivalent to 25mg sample wt. of Rcecadotril. diluted to 100 ml volumetric with solvent mixture.
Wavelength -231 nm
Flow rate- 1.2 ml/mint.
C18 (250 x4.6) 5 micron
Injection volume :50 µl
|Sr. No.||Abbreviation used||Full form of abbreviation used|
|1.0||STP||Standard Testing Procedure|
7.0 ATTACHMENTS (ANNEXES)