Analysis method of Terbinafine HCL Cream
1.1 To lay down a procedure for analysis of Terbinafine HCL Cream.
2.1 This procedure is applicable to the analysis of Terbinafine HCL Cream.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.
Terbinafine HCL USP 1.0% w/w
Estimation of Terbinafine HCL:
Method of Terbinafine HCL:
Mobile phase: A mixture of 500 volume of water,400 volumes of Acetonitrile,100 volumes of
Methanol,1 volume of orthophoshoric acid and 1 volume of triethylamine.
Standard preparation: Weight 25mg. of Terbinafine hydrochloride diluted to 50 ml volumetric flask with Methanol.
Further dilution 5 ml to 50ml volumetric flask with Methanol.
Sample preparation: Weight accurately equivalent to 25mg.of sample wt. With 70 ml. of Methanol warm on water bath at 550 for
10 minute. Sonicate for 15-minute cool to room temperature and dilute to 100 ml with Methanol. Further dilute 5 ml to 25 ml with Methanol.
Flow rate – 1.0ml/mint.
column – C18(250 mm X 4.6) (5μm),
Injection volume – 20 µl.
Column temp. – Ambient.
|Sr. No.||Abbreviation used||Full form of abbreviation used|
|1.0||STP||Standard Testing Procedure|
|Sr. No.||Reference Title|