HPLC Analysis of Terbinafine HCl Cream on Purospher® Star Phenyl (5μm) 150 x 3 mm
CONDITIONS
sample preparation
Dissolve appropriate amount of Terbinafine Hydrochloride Cream in isopropanol to obtain a 0.2 mg/mL (200 ppm) of solution, filter prior to analysis. Light degradation solution expose 1mg/mL of Terbinafine Hydrochloride in 50% ACN solution at 254 nm of UV light for 1h. Inject the solution to HPLC system, 3 major related impurity can be found with relative retention time (RRT) from 0.8 to 1.2 (Generally 0.87, 0.95,1.1).
column
Purospher® STAR RP-18 endcapped (5 mm) 150 x 3 mm (1.50626.0001)
mobile phase
Mobile Phase A - [A] 2.0 mL/L of triethylamine. Adjust pH 7.5 with glacial acetic acid; [B] methanol; [C] acetonitrile; (30:42:28, A:B:C). Mobile Phase B - [A] 2.0 mL/L of triethylamine. Adjust pH 7.5 with glacial acetic acid; [B] methanol; [C] acetonitrile; (5:57:38, A:B:C)
gradient
Time (min), A (%), B (%); 0, 100, 0; 4, 100, 0; 25, 0, 100; 30, 0, 100; 31, 100, 0; 38, 100, 0;
flow rate
0.8 mL/min
pressure
2407 psi (166 Bar)
column temp.
25 °C
detector
280 nm cell: 1 μL/10 mm
injection
20 μL
sample
Dilute appropriate amount of standard with isopropanol to obtain a 0.2 mg/mL (200 ppm) solution.
Description
Legal Information
Purospher is a registered trademark of Merck KGaA, Darmstadt, Germany