Ketotifen Analyzed by HPLC - AppNote
July 25, 2012
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API with a Tertiary Amine can have a Great Peak Shape
The tertiary amine group of Ketotifen makes it a challenging compound to analyze in HPLC. In addition to good peak shape for this API, another peak can be identified which is baseline resolved from the main peak of interest.
This Method is suitable for routine assay of Ketotifen in ophthalmic solutions and is Precise as indicated by the overlay of 5 runs in Figure B. Also, the Method conditions were developed to be LCMS compatible which would be a great next step to identify peak 1.
Column: Cogent Silica-C™, 4 μm, 100 Å
Catalog No.: 40000-7.5P
Dimensions: 4.6 x 75 mm
Mobile Phase:
-- A: DI Water / 0.1% Formic Acid
-- B: Acetonitrile / 0.1% Formic Acid
Gradient:
Post Time: 3 minutes
Injection vol.: 1 μL
Flow rate: 1.0 mL / minute
Detection: UV @ 268 nm
Sample Preparation: Equate® brand eye drop solution containing 0.035% Ketotifen Fumarate was filtered with 0.45 μm Nylon Syringe Filter (MICROSOLV Tech Corp.) and used for injection.
t 0 : 0.9 minutes
Note: Ketotifen is a second-generation noncompetitive H1-Antihistamine. In addition to ophthalmic solutions, it is also available in tablet formulations as well. In the latter case, it is used in treatment of asthma. It is marketed under trade
names such as Zyrtec®, Zaditor®, and Alaway®.
Attachment No 196 Tertiary Amine - Ketotifen Analyzed by HPLC pdf 0.4 Mb Download File
The tertiary amine group of Ketotifen makes it a challenging compound to analyze in HPLC. In addition to good peak shape for this API, another peak can be identified which is baseline resolved from the main peak of interest.
This Method is suitable for routine assay of Ketotifen in ophthalmic solutions and is Precise as indicated by the overlay of 5 runs in Figure B. Also, the Method conditions were developed to be LCMS compatible which would be a great next step to identify peak 1.
Peaks:
1. Matrix component,
2. Ketotifen
Column: Cogent Silica-C™, 4 μm, 100 Å
Catalog No.: 40000-7.5P
Dimensions: 4.6 x 75 mm
Mobile Phase:
-- A: DI Water / 0.1% Formic Acid
-- B: Acetonitrile / 0.1% Formic Acid
Gradient:
| Time (minutes) | %B |
|---|---|
| 0 | 95 |
| 2 | 95 |
| 6 | 40 |
| 7 | 95 |
Post Time: 3 minutes
Injection vol.: 1 μL
Flow rate: 1.0 mL / minute
Detection: UV @ 268 nm
Sample Preparation: Equate® brand eye drop solution containing 0.035% Ketotifen Fumarate was filtered with 0.45 μm Nylon Syringe Filter (MICROSOLV Tech Corp.) and used for injection.
t 0 : 0.9 minutes
Note: Ketotifen is a second-generation noncompetitive H1-Antihistamine. In addition to ophthalmic solutions, it is also available in tablet formulations as well. In the latter case, it is used in treatment of asthma. It is marketed under trade
names such as Zyrtec®, Zaditor®, and Alaway®.
Attachment No 196 Tertiary Amine - Ketotifen Analyzed by HPLC pdf 0.4 Mb Download File