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Impurity profile of Tivicay Tablets

IP.com Disclosure Number: IPCOM000238674D
Publication Date: 2014-Sep-11
Document File: 2 page(s) / 64K

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The IP.com Prior Art Database

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Impurity profile of Tivicay Tablets

Described hereinafter is a chromatographic purity profile of Tivicay tablet, purchased in US on 2/2014 having the following details: Tivicay 50mg, 30 Tabs/ lot # 4ZP2702; expiry date: Nov.2015; Manufactured by GlaxoSmithKline, made in Japan

Tivicay (Sodium (4R,12aS)-9-((2,4-difluorobenzyl)carbamoyl)-4-methyl-6,8-dioxo- 3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazin-7-olate ) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Tivicay tablets of 50mg were evaluated for impurity profile by reversed phase HPLC method according to the following example:

50 mg TIVICAYtablet was dissolved in diluent, and then filtered into a HPLC vial. Chromatographic analysis was performed by HPLC using the following conditions:

Column:

Eluent A:

Eluent B:

Gradient:

Re-equilibration time: 5 min Injection volume:

2 µL

Flow Rate:

Detector:

                    UV 210 nm Columntemperature: 50C Diluent:

Water :ACN (50:50)

ACQUITY UPLC BEH C18, 1.7 m, 100*2.1mm

90% (Buffer 2 mM NH4H2PO4, 0.002%w/v EDTA, pH = 7.0)

: 10% ACN

50% Acetonitrile: 50% Methanol

Time (min) % Eluent A % Eluent B 0 100

0

2 100

8 84

21 48

53 53

83 53

0

16

21

03

03


0.5 mL/min


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The following results were obtained:

RTmin 16.91 0.86 6.95 8.63 16.02 17.41 26.36 38.12 RRT 1.00 0.05 0.41 0.51 0.95 1.03 1.56 2.25

%area 98.3 0.01 0....