Validated Methods

LC/MS Biomarkers | Immunoassay Biomarkers | LC/MS Drug Assays

Advion Bioanalytical Labs specializes in validated LC/MS methods development to support drug-drug interaction (DDI), biomarker, or comparison studies with established therapeutic compounds. Non-proprietary, validated methods offer a cost-effective and timely solution for clients.

Click on the validated method name to request additional information such as the anticoagulant used, accuracy and precision, and stability details for the assay.

Advion Bioanalytical Labs is happy to partner with new and existing clients to develop assays that have value to the pharmaceutical industry. If there is a method you feel we should offer, please email us at clinical@quintiles.com.

Validated LC/MS/MS Methods (PDF of Validated Methods)

Analyte/MetaboliteRangeExtraction VolumeMatrix/Anticoagulant
Acyclovir/Valaciclovir10 - 1000 ng/mL50 µLHuman plasma/      K3EDTA
Amlodipine0.1 - 10 ng/mL100 µLHuman plasma/ heparinized
D-Amphetamine, L-Amphetamine (chiral)0.5 - 75 ng/mL200 µLHuman plasma/  sodium EDTA

Available soon

D-Amphetamine (achiral)

0.5 - 200 ng/mL100 µLHuman plasma/  sodium EDTA
Atorvastatin/o-Hydroxyatorvastatin; p-Hydroxyatorvastatin0.25 - 25 ng/mL200 µLHuman plasma/ sodium heparin
Bortezomib0.1 - 25 ng/mL100 µLHuman plasma/      K3EDTA and       sodium heparin
Capecitabine/5'-DFCR;
5'-DFUR;
5-FU;
FBAL
10 - 5000 ng/mL
50 - 25000 ng/mL
2 - 1000 ng/mL
15 - 7500 ng/mL
200 µLHuman plasma/ sodium EDTA
Carbamazepine/
Carbamazepine-10, 11 epoxide
20 - 5000 ng/mL
20 - 500 ng/mL
50 µLHuman plasma/ sodium EDTA
Clopidogrel;
Clopidogrel Carboxylic Acid; Clopidogrel Active Metabolite
0.05 - 50 ng/mL
5 - 5000 ng/mL
0.0706 - 70.6 ng/mL
200 µLHuman plasma/      K2EDTA
Cytarabine25 - 1000 ng/mL20 µLHuman plasma/ sodium heparin
Daunorubicin/Daunorubicinol1 - 500 ng/mLTBDHuman plasma/      K2EDTA
Digoxin0.1 - 20 ng/mL200 µLHuman serum
Digoxin5 - 1000 ng/mL100 µLHuman urine
Available soon
Docetaxel
1 - 2500 ng/mL200 µLHuman plasma/      K2EDTA
Donepezil0.2 - 100 ng/mL200 µLHuman plasma/ sodium heparin

Duloxetine/                        Atomoxetine; S,S-Reboxetine

0.2 - 200 ng/mL 0.5 - 500 ng/mL

50 µLHuman plasma/      K3EDTA
Erlotinib1 - 3000 ng/mL50 µLHuman plasma/ sodium heparin
5-Fluorouracil (5-FU)10 - 10000 ng/mL100 µLHuman plasma/   sodium heparin and K2EDTA
Fenofibric Acid20 - 10000 ng/mL100 µLHuman plasma/ sodium EDTA
Gemcitabine10 - 10000 ng/mL25 µLHuman plasma/ lithium heparin
Glyburide0.025 - 2 ng/mL100 µLHuman PFF        (non-protein bound)
Glyburide (total)1 - 250 ng/mL200 µLHuman plasma/ sodium heparin
Imatinib (Gleevec®)/
N-Desmethyl Imatinib
100 - 10000 ng/mL
50 - 5000 ng/mL
50 µLHuman plasma/          K2EDTA
Lamivudine (as part of Combivir®)2 - 1000 ng/mL200 µLHuman plasma/ sodium heparin
Lamivudine (as part of Combivir®)2 - 1000 ng/mL200 µLHuman urine
Lovastatin/Lovastatin Acid0.25 - 100 ng/mL500 µLHuman plasma/ sodium heparin
Methotrexate/
7-Hydroxymethotrexate
1 - 1000 ng/mL
1 - 150 ng/mL
200 µLHuman plasma/ lithium heparin
Methotrexate (Low Curve)/
7-Hydroxymethotrexate
50 - 1000 ng/mL20 µLHuman urine
Methotrexate (High Curve)/
7-Hydroxymethotrexate
1000 - 50000 ng/mL
50 - 1000 ng/mL
20 µLHuman urine
Methylphenidate/                α-Phenyl-α-(2-Piperidyl)Acetic Acid0.05 - 25 ng/mL100 µLHuman plasma/   acid citrate dextrose
Midazolam/1-Hydroxymidazolam0.1 - 100 ng/mL100 µLHuman plasma/ sodium and         lithium heparin
Moxifloxacin25 - 5000 ng/mL50 µLHuman plasma/          K2EDTA
Omeprazole/
5-Hydroxyomeprazole; Omeprazole Sulfone
0.5 - 500 ng/mL
0.5 - 250 ng/mL
50 µLHuman plasma/   sodium heparin
Paclitaxel/6-Hydroxypaclitaxel10 - 5000 ng/mL200 µLHuman plasma/          K2EDTA
Ritonavir10 - 5000 ng/mL50 µLHuman plasma/      K3EDTA
Rosiglitazone5 - 3000 ng/mL25 µLHuman plasma/      K3EDTA
Rosuvastatin/
Rosuvastatin Lactone; N-Desmethyl Rosuvastatin
0.5 - 100 ng/mL
0.5 - 50 ng/mL
100 µLHuman plasma/          K2EDTA
Simvastatin/Simvastatin Acid0.1 - 30 ng/mL200 µLHuman plasma/      K3EDTA
Tolterodine/
5-Hydroxymethyltolterodine
0.2 - 50 ng/mL100 µLHuman plasma/ sodium heparin
Valproic Acid1 - 100 µg/mL100 µLHuman serum
R-Warfarin, S-Warfarin (chiral)0.1 - 10 ng/mL200 µLHuman PFF
(non-protein bound)
R-Warfarin, S-Warfarin (chiral)1 - 2500 ng/mL100 µLHuman plasma (total)/sodium and lithium heparin
Zidovudine (as part of Combivir®)2 - 1000 ng/mL200 µLHuman plasma/ sodium heparin
Zidovudine (as part of Combivir®)2 - 1000 ng/mL200 µLHuman urine
Ziprasidone0.5 - 150 ng/mL200 µLHuman plasma/ sodium heparin

 LC/MS Biomarker Methods

Biomarker Method Development and Validation Expertise
Amino Acids
Rat Hepcidin
Lipids
Neurotransmitters
Nucleotides
Peptides
Proteins – immunoprecipitation, digestion, immunoaffinity LC/LC/nano LC/MS/MS

Immunoassay Biomarker Methods

Biomarker/Analyte on ELISA PlatformRangeVolume RequiredMatrix
HER-2/neu2.5 - 35 ng/mL20 µLHuman serum

β-NGF (free)

1 – 500 pg/mL50 µLHuman serum
IGF-1 (total)0.15 - 6 ng/mL20 µLHuman serum
IGF-1 (free)0.15 - 6 ng/mL20 µLHuman serum
sECAD0.625 - 20 ng/mL20 µLHuman serum
sEGFr12.5 - 300 ng/mL20 µLHuman serum