HPLC Analysis of Simvastatine USP on Chromolith^® High Resolution RP-18e (analyte set 2)

sample preparation

1.4mg/ml monobasic potassium phosphate in water - Diluent: Acetonitril and Buffer 3:2

column

Chromolith High Resolution RP-18 endcapped, 50 x 4.6 mm (1.52021.0001)

mobile phase

[A] 50% Acetonitril, 50% phosphoric acid and water 1:999; [B] 100% phosphoric acid and Acetonitril 1:999;

gradient

100% A held for 4.5 min; to 95% A for 3.5 min; to 25% A for 3.5 min; to 100% A held for 1.5 mins; Original: Initial composition:0-4.5min 100%A, 4.6min to 8 min 95%A to 25%A (8min to 11.5min 25%A, 11.6min to 13min 100%A)

flow rate

3 mL/min

column temp.

ambient

detector

238 nm (cell: 11 μL)

injection

5 μL

sample

Lovastatin (1,5mg/ml), Simvastatin (1,5mg/ml) (Diluent: Acetonitril and Buffer 3:2)