Benzonatate Excipients and Degradants Analyzed by HPLC - AppNote
May 10, 2012
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Date: 10-MAY-2012 Last Updated: 16-SEPTEMBER-2026
A Simple, Linear Gradient for a Challenging Drug Product
This Gradient Method will produce a good separation of Benzonatate from excipients and degradants in a USP Capsule Formulation. Benzonatate contains a secondary amine group, which can cause peak tailing.
Peak: Benzonatate
Method ConditionsColumn: Cogent Bidentate C18™, 4 μm, 100 Å
Catalog No.: 40018-75P
Dimensions: 4.6 x 75 mm
Mobile Phase:
-- A: DI Water / 10 mM Sodium Phosphate Monobasic
-- B: 80% Acetonitrile / 20% DI Water / 10 mM Sodium Phosphate Monobasic
Gradient:
| Time (minutes) | %B |
|---|---|
| 0 | 0 |
| 15 | 100 |
Injection vol.: 10 μL
Flow rate: 1.5 mL/minute
Detection: UV @ 280 nm
Notes: Benzonatate is a non-narcotic oral antitussive (cough suppressant) drug, taken orally, which works by anesthetizing the tissues of the lungs and pleura responsible for the cough reflex. It is sold under the brand name Tessalon Perles (gelcaps) or Tessalon Capsules.
