Analysis method of Deflazacort Suspension
1.1 To lay down a procedure for analysis of Deflazacort Suspension.
2.1 This procedure is applicable to the analysis of Deflazacort Suspension 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 with the reference solution.
Each 5.0 ml contains:
Estimation of Deflazacort Suspension:
Method of Deflazacort Suspension:
Method: BY HPLC
Mobile phase: Water : ACN
55 : 45
Standard preparation: Weight 60 mg of Deflazacort Suspension diluted to 100 ml Acetonitrile, further dilute 5 ml to 50 ml volumetric flask in Acetonitrile.
Test preparation: Weight accurately each 5 ml contains. Weight to 100 ml volumetric flask with dilute Acetonitrile.
Flow rate- 1.5 ml /mint.
column c18 (150 x4.6) 5 micron
Temperature: Ambient Temp.
Retention time: about 6.5 mint.
|Sr. No.||Abbreviation used.||Full form of abbreviation used.|
|1.0||STP||Standard Testing Procedure.|
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