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Kalydeco tablet

IP.com Disclosure Number: IPCOM000228763D
Publication Date: 2013-Jul-04
Document File: 1 page(s) / 56K

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Kalydeco tablet


N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide

has the following chemical structure and :

Compound I

Chromatographic purity of Kalydeco tablet (Lot. No. 280267, expiry date: April 2014,

bought from US market):

A Kalydeco tablet, which contains 150mg of Ivacaftor, was milled with pestle and

mortar. About 40mg of this powder was weighed twice and extracted - once with

Acetonitrile and once with Methanol. Those samples were analyzed using the

following HPLC method:

The obtained purity results are as follows:

Column & packing: Ascentis Express C8 150*4.6mm, 2.7μm Eluent A:

98% Water - 2% Acetonitril (AcN) - 0.01% Trifluoroacetic (TFA) acid

80% AcN - 20% Water - 0.01% TFA acid

Gradient of Eluent: Time (min) Eluent A (%) Eluent B (%)

0

100

0

25

20

80

30

20

80

Stop time:

                30 min Equilibration time: 6 min Flow:

0.9ml/min

Eluent B:

                210nm Injection volume: 5 l Column temperature: 250C

Detector:

Kalydeco_Tablet- Lot. No. 280267 extracted with MeOH impurity

Compound I

RT


19.80


27.30


0.73

RRT

[M+H]+= 425


1.00

% on area


0.05


99.95

Kalydeco_Tablet- 280267 extracted with ACN impurity

Compound I

RT


19.80


27.30


0.73

RRT

[M+H]+= 425


1.00

% on area


0.04


99.96