Assay Method for the Analgesic Nucynta

Tapentadol can be a problematic compound for HPLC analysis due to the Amine functional group. Tertiary amines are often particularly difficult to obtain a good peak shape using Reversed Phase methods. Peak tailing has been reported in several published papers in the literature.

With this Method, a sharp Peak is obtained due to the unique retention mode. Data from two column lots shown in the figure illustrates the reproducibility of the Method and its robustness.

Peak:
Tapentadol HCI

Method Conditions
Column: Cogent Diamond Hydride™, 4µm, 100Å
Catalog No.: 70000-7.5P
Dimensions: 4.6 x 75mm
Mobile Phase:
A: DI Water / 0.1% Formic Acid (v/v)
B: Acetonitrile / 0.1% Formic Acid (v/v)
Gradient:

Time (minutes) %B
0 95
1 95
6 40
7 95

Post Time: 3 minutes
Injection vol.: 1µL
Flow rate: 1.0mL / minute
Detection: UV @ 271nm
Sample Preparation: 75mg strength Nucynta® tablet was ground and weighed in a 25mL volumetric flask. A portion of 50:50 Solvent A / Solvent B diluent was added and the flask was sonicated 10 minutes. It was then diluted to mark and filtered with a 0.45µm Nylon Syringe Filter (MicroSolv Tech Corp.). The filtrate was diluted 1:5 for HPLC injections.
t0: 0.9 minutes

Note: Tapentadol is an analgesic compound used to treat moderate to severe pain. Its efficacy is due to two modes of action: one is an agonist of the µ-opioid receptor and another as a norepinephrine reuptake inhibitor.

Attachment

No 234 Nucynta Tapentadol HCl Tablet Analyzed with HPLC pdf  0.3 Mb  Download File

image_pdfDownload this Page