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Overview Butamben is a local anesthetic and is the ester of 4- aminobenzoic acid and butanol. This application note for the LC-UV assay and organic impurities for Butamben is based on the official USP method, which was developed utilizing a Kinetex 5 µm XB-C18 100 x 2.1 mm core-shell LC column, as indicated in the USP Chromatographic Columns 1 . The standard and system suitability solutions for the assay and organic impurities were prepared in accordance with the USP monograph. The system suitability requirements for the assay: peak symmetry NMT 2.0 for butamben, and RSD NMT 0.73 % for butamben were easily achieved. In order to meet the system suitability requirements for the organic impurities: resolution NLT 10 between the amino- benzoic acid and butamben peaks, and RSD NMT 5% for each peak corresponding to aminobenzoic acid and butamben, the injection volume was increased to 5 µL. 1. USP Chromatographic Columns (https://www.uspchromcolumns.com/chrom/display). USP Butamben Assay and Organic Impurities by LC-UV using the Kinetex® 5 µm XB-C18 Core- Shell HPLC Column Zeshan Aqeel and Phil Koerner Phenomenex, Inc., 411 Madrid Ave., Torrance, CA 90501 USA Page 1 of 3 LC-UV Conditions Column: Dimension: Part No.: Mobile Phase: Gradient: Flow Rate: Temperature: Detector: Injection: System: Sample: Kinetex 5 µm XB-C18 100 x 2.1 mm 00D-4605-AN A: 0.1% formic acid in Water B: 0.1% formic acid in Acetonitrile Time (min) % B 0 10 1 10 6 50 8.5 50 8.6 90 10 90 0.4 mL/min 30 °C UV @ 285 nm 1 µL (assay); 5 µL (impurities) Agilent® 1260 Infinity (binary) As indicated in each chromatogram
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![Page 1: h^W µ u v Ç v K P v ] / u µ ] ] Ç > rhs µ ] v P Z < ] v Æ ...](https://reader040.fdocuments.net/reader040/viewer/2022040409/6248bf8a46b6fc7cce6475d6/html5/page/1.jpg)
OverviewButamben is a local anesthetic and is the ester of 4-aminobenzoic acid and butanol. This application note for the LC-UV assay and organic impurities for Butamben is based on the official USP method, which was developed utilizing a Kinetex 5 µm XB-C18 100 x 2.1 mm core-shell LC column, as indicated in the USP Chromatographic Columns1. The standard and system suitability solutions for the assay and organic impurities were prepared in accordance with the USP monograph.
The system suitability requirements for the assay: peak symmetry NMT 2.0 for butamben, and RSD NMT 0.73 % for butamben were easily achieved. In order to meet the system suitability requirements for the organic impurities: resolution NLT 10 between the amino-benzoic acid and butamben peaks, and RSD NMT 5% for each peak corresponding to aminobenzoic acid and butamben, the injection volume was increased to 5 µL.
1. USP Chromatographic Columns (https://www.uspchromcolumns.com/chrom/display).
USP Butamben Assay and Organic Impurities by LC-UV using the Kinetex® 5 µm XB-C18 Core-Shell HPLC ColumnZeshan Aqeel and Phil KoernerPhenomenex, Inc., 411 Madrid Ave., Torrance, CA 90501 USA
Page 1 of 3
LC-UV ConditionsColumn:
Dimension:Part No.:
Mobile Phase:
Gradient:
Flow Rate:Temperature:
Detector:Injection:
System:Sample:
Kinetex 5 µm XB-C18100 x 2.1 mm 00D-4605-ANA: 0.1% formic acid in WaterB: 0.1% formic acid in AcetonitrileTime (min) % B
0 101 106 508.5 508.6 90
10 900.4 mL/min30 °CUV @ 285 nm1 µL (assay); 5 µL (impurities)Agilent® 1260 Infinity (binary)As indicated in each chromatogram
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min2 4 6 8
mAU
-1
0
1
2
3
DAD1 A, Sig=285,4 Ref=360,100 (C:\USERS\P...DATA\ZA121220\BUTAMBEN 2020-12-15 14-01-12\Butamben0000004.D)
Area: 4
.99656
1.2
70
Area: 5
.7655
7.3
39
min2 4 6 8
mAU
0
50
100
150
200
250
300
350
400
DAD1 A, Sig=285,4 Ref=360,100 (C:\USERS\P...ZA121220\BUTAMBEN 2020-12-14 10-35-01\Butamben0000007--005.D)
7.2
96
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Figure 1: Standard Solution for Assay (0.2 mg/mL Butamben RS)
App
ID 2
6337
Sample: 1. Butamben
Results – Standard Solution (Assay)
Kinetex 5 µm XB-C18
AnalyteRetention Time, min
Resolution, NLT 10
RSD, NMT 5%(n = 6)
Aminobenzoic acid 1.26 3.13
Butamben 7.34 83 2.96
Sample: 1. Aminobenzoic acid2. Butamben
App
ID 2
6338
Kinetex 5 µm XB-C18
AnalyteRetention Time, min
Symmetry Factor, NMT 2.0
RSD, NLT 0.73%
(n = 5)
Butamben 7.30 1.10 0.36%
Results – Standard Solution (Organic Impurities)
Figure 2: Standard Solution for Organic Impurities (0.2 μg/mL each of Butamben RS andAminobenzoic Acid RS)
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Terms and ConditionsSubject to Phenomenex Standard Terms and Conditions, which may be viewed at www.phenomenex.com/TermsAndConditions.TrademarksKinetex is a registered trademark and BE-HAPPY is a trademark of Phenomenex.Agilent is registered trademark of Agilent Technologies, Inc .DisclaimersPhenomenex is in no way affiliated with Agilent.FOR RESEARCH USE ONLY. Not for use in clinical diagnostic procedures.© 2021 Phenomenex, Inc. All rights reserved.
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