Analysis method of Tacrolimus Ointment
1.1 To lay down a procedure for analysis of Tacrolimus Ointment.
2.1 This procedure is applicable to the analysis of Tacrolimus Ointment. in 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.
5.2.1 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.
5.3 Average fill weight: Weigh accurately bulk of 20 tube and calculate the average fill weight.
Average fill Weight = fill weight of 20 tube/20.
Tacrolimus IP 0.1% w/w
Method of Tacrolimus:
Mobile phase: A mixture of 600 volumes of 6Mm Orthophoshoric acid,55 volume tetrabutylmethyl ether and 335 volumes of Acetonitrile.
Diluent: 30 volume of dissolving 50gm. Of polyoxyethylene (23) lauryl ether in 1000ml water and 70
volume of Acetonitrile.
Standard preparation: Weight 25 mg. of Tacrolimus add 50 ml diluent. Sonicates to be dissolve and dilute 100 ml volumetric flask with diluent.
Further dilution 5 ml to 50ml volumetric flask with Diluent.
Sample preparation: Weight accurately 2.5 gm. of sample wt. Add 50 ml diluent. Heat 500c then cool and sonicate. The volume was make up 100 ml volumetric flask with diluent.
Flow rate – 1.0ml/mint.
column – C18(5.5cm X 4.6mm) (5μm),
Injection volume – 5 µl.
Column temp. – 600
|Sr. No.||Abbreviation used||Full form of abbreviation used|
|1.0||STP||Standard Testing Procedure|
|Sr. No.||Reference Title|