LC Technical Note

LT182

GL Sciences Inc.

Analysis of Copovidone- Under the Condition of the EP 10th ed.

The Pharmacopoeial Discussion Group agreed on the international harmonization of copovidone, apharmaceutical additive. Following this agreement, the tests of copovidone in European Pharmacopoeia(EP) have been revised in the 10th edition, which was implemented on the 1st of January, 2020.
The revision consists of the change of the analytical conditions of Impurity A (2-pyrrolidone) and newly
added Impurities B and C (1-vinylpyrrolidin-2-one and vinyl acetate, respectively) tests. This technical note
describes representative examples of these tests obtained with Inertsil ODS-4, which is opted for thesetests.

EP: Impurity A

0100mAU200

10Conditions

10Guard Column : Inertsil ODS-4(5 μm, 10 x 4.0 mm I.D.)
Column: Inertsil ODS-4(5 μm, 150 x 4.6 mm I.D.)
Eluent: A) CH3OH
B) H2O
A/B = 5/95, v/v
Flow Rate: 0.8 mL/min
Col. Temp.
: 40 ℃
Detection: UV 205 nm
Injection Vol.
: 20 μL
Sample: StandardTime (min)2030Analyte:
1. 2-Pyrrolidone（Impurity A）

45 mg/L

Symmetry factor: 1.27 (≦ 1.5)*
RSD of the peak area (%)(n=6): 0.10 (≦ 2.0)** （）：pharmacopeia standard values

GL Sciences LC Technical NotemAU

2EP：Impurities B and C

2UV 205 nm

01-a0

1020Time (min)3040mAU

21-b0

UV 235 nm

0Conditions

10Guard Column : Inertsil ODS-4(5 μm, 33 x 4.0 mm I.D.)
Column: Inertsil ODS-4(5 μm, 250 x 4.0 mm I.D.)
Eluent: A) CH3CNB) H2O
A/B = 8/92, v/v
Flow Rate: 1.0 mL/minCol. Temp.
: 40 ℃
Detection: UV 205 or 235 nm
Injection Vol.
: 20 μL
Sample: Standard

20Time (min)30

Analyte:1. 1-Vinyl-2-pyrrolidone（Impurity B）
2. Vinyl acetate（Impurity C）

40

0.25 mg/L
0.25 mg/L

Resolution (1-a,2): 11.75 (≧ 2.0)*
RSD of the peak area of 1-b (%)(n=6): 1.33 (≦ 2.0)
RSD of the peak area of 2 (%)(n=6)*: 0.50 (≦2.0)* （）：pharmacopeia standard values

Note: After each injection of the test solution, elute andwash away the remaining sample by passing the mobile
phase through the column backwards for about 30 min at
the same flow rate as applied in the test. This process may
be replaced by washing the precolumn only.

GL Sciences LC Technical Note
Product Information
Columns for Impurity A test

Columns for Impurities B and C test

Column（EP 10th ed.）：Precolumn:-size: l=0.010 m, Φ=4.0 mm;-stationary phase:base-deactivated end-capped octadecylsilyl
silica gel for chromatography R（5 μm）.
Analytical Column:-size: l=0.15 m, Φ=4.6 mm;-stationary phase:base-deactivated end-capped octadecylsilyl
silica gel for chromatography R（5 μm）.

Column（EP 10th ed.）：Precolumn:-size: l=0.033 m, Φ=4.0 mm;-stationary phase:base-deactivated end-capped octadecylsilyl
silica gel for chromatography R（5 μm）.
Analytical Column:-size: l=0.25 m, Φ=4.0 mm;-stationary phase:base-deactivated end-capped octadecylsilyl
silica gel for chromatography R（5 μm）.

●Precolumn: Inertsil ODS-4 5 μm, 10 x 4.0 mm I.D.
Cat.No. 5020-03651●Precolumn: Inertsil ODS-4 5 μm, 33 x 4.0 mm I.D.
Cat.No. 5020-04251●Analytical column: Inertsil ODS-4 5 μm, 150 x 4.6 mm I.D.
Cat.No. 5020-03945●Analytical column：Inertsil ODS-4 5 μm, 250 x 4.0 mm I.D.
Cat.No. 5020-03936●Connection between the guard and analytical columns
PEEK tubing of 1/16” O.D., 0.25 mm I.D. was cut to 5 cm andconnected by PEEK tough fittings.
●Related connection products
・PEEK tubing (1/16” O.D., 0.25 mm I.D., 5 m long)
Cat.No.6010-37305
・PEEK tough fitting, 5/pk
Cat.No.6010-48600
・Pre-column coupler UP 0.25 mm I.D.
Cat.No.6010-49201
・Pre-column coupler SUS 0.25 mm I.D.
Cat.No.6010-49250

GL Sciences disclaims any and all responsibility for any injury or damage which may be caused by this data directly or indirectly.
We reserve the right to amend this information or data at any time and without any prior announcement.

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