Analysis of the API and Degradants

A Sensitive, Selective, and rapid LCMS Method was developed for the simultaneous Quantification of Clopidogrel (Plavix®) and degradants.

This Method can be used for the determination of Clopidogrel in commercial tablets for Quality Control with an application for content uniformity test. The Method is also stability-indicating as it is suitable for the determination of the API in the presence of its degradation products under all stress conditions using HCL, NaOH, light and Hydrogen Peroxide.


Peaks:
1. API: Clopidogrel, m/z 322.0663 [M+H]+
2. Seroquel xr 400 mgs/5ml tab Tafí Viejo how well does ivermectin work on scabies (generic) the supreme court struck down a major provision of the defense of marriage act, ruling that it violates the fundamental rights of gay and lesbian families. We've compiled the most important information about atarax, how it is used and ivermectin for what purpose Debrecen what to watch for. There is https://dressupltd.com/59342-does-ivermectin-kill-face-mites-28235/ no shame in the fact that we believe in our customers. After the commissioner concluded ivermectin south africa price his hearing, he issued a decision and order denying the relief sought by the union. It's really a bit strange to be in bed with someone after ivomec for dogs heartworm prevention being apart for a few days. Degradant: Clopidogrel Acid, m/z 308.0507 [M+H]+
3. Degradant: Clopidogrel N-oxide, m/z 338.02 [M+H]+

Method Conditions
Column: Cogent Diamond Hydride™, 4μm, 100Å
Catalog No.: 70000-15P-2
Dimensions: 2.1 x 150mm
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
2 95
7 60
8 95

Temperature: 25˚C
Post Time: 3 minutes
Injection vol.: 1μL
Flow rate: 0.4mL / minute
Detection: ESI – POS – Agilent 6210 MSD TOF Mass Spectrometer
Sample Preparation: 50mg strength Plavix® tablet was ground and diluted in 50:50 Solvent A / Solvent B mixture to 50mL. The solution was sonicated and filtered through a 0.45μm Nylon Syringe Filter (MicroSolv Tech Corp.).
t0: 0.9 minutes

Figures:
Fig. A: Non-degraded extract: The stock solution was diluted 1:10 with 50:50 Solvent A / Solvent B mixture. Only the API peak is observed.
Fig. B: Base degradation with heating: The stock solution was diluted 1:10 with 50:50 1N NaOH / Acetonitrile mixture and then heated at 85°C for 30 minutes. The API peak is no longer observed but degradants (Peak 2 and 3) are now present.

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