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List of validated methods

List of validated methods


Bioanalytical method development and validation is carried out according FDA and EMA requirements. Highly sensitive analytical method can be developed in accordance with clinical protocol requirements.

The list of validated methods:

Compound

(Metabolite, Biomarker)

Matrix

Method

LLOQ

Status*

Abacavir

Plasma

LC-MS/MS

50 ng/mL

Active

Abacavir/

Lamivudine

Plasma

LC-MS/MS

50 ng/mL

50 ng/mL

Active

Abiraterone

Plasma

LC-MS/MS

0.2 ng/mL

Active

Acetaminophen /

Chlorpheniramine

Plasma

LC-MS/MS

10 ng/mL

0.1 ng/mL

Active

Acetylsalicylic acid /

Salicylic acid

Plasma

LC-MS/MS

4 ng/mL

15 ng/mL

Active

Ademethionine

Plasma

LC-MS/MS

10 ng/mL

Active

Ambroxol

Plasma

LC-MS/MS

1 ng/mL

Active

Ambroxol /

Cetirizine

Plasma

LC-MS/MS

1 ng/mL

4 ng/mL

Active

p-Aminosalicylic acid

Plasma

LC-MS/MS

50 ng/mL

Active

Amlodipine

Plasma

LC-MS/MS

0.2 ng/mL

Active

Amlodipine /

Metoprolol

Plasma

LC-MS/MS

0.2 ng/mL

0.1 ng/mL

Active

Amlodipine /

Telmisartan

Plasma

LC-MS/MS

0.2 ng/mL

2.5 ng/mL

Active

Amoxicilline /

Clavulanic acid

Plasma

LC-MS/MS

100 ng/mL

50 ng/mL

Active

Anandamide

Plasma

LC-MS/MS

0.1 ng/mL

Active

2-Arachidonoyl glycerol

Plasma

LC-MS/MS

0.5 ng/mL

Active

Arginine

Plasma

LC-MS/MS

4 µg/mL

Active

Atazanavir

Plasma

LC-MS/MS

5 ng/mL

Active

Atorvastatin

Plasma

LC-MS/MS

0.2 ng/mL

Active

Bosentan

Plasma

LC-MS/MS

5 ng/mL

Active

Bicalutamide

Plasma

LC-MS/MS

10 ng/mL

Active

Capecitabine /

5-Fluorouracil

Plasma

LC-MS/MS

20 ng/mL

20  ng/mL

Active

Celecoxib

Plasma

LC-MS/MS

10 ng/mL

Active

Cetirizine (Levocetirizine)

Plasma

LC-MS/MS

1 ng/mL

Active

Cinacalcet

Plasma

LC-MS/MS

0.1 ng/mL

Active

Cisplatine

Plasma

LC-MS/MS

1 ng/mL

Active

Citalopram

Plasma

LC-MS/MS

0.3 ng/mL

Active

Coenzyme Q10  /

reduced Coenzyme Q10 (ubiquinol)/

Coenzyme Q9

Plasma

Tissue

LC-MS/MS

1 µg/mL

Active

Corticosterone

Urine

HPLC/UV

5 ng/mL

Active

Cortineff

Urine

LC-MS/MS

1 ng/mL

Inactive

Cortisol (6ß-Hydroxycortisol)

Urine

HPLC/UV

5 ng/mL

Active

Cortisone

Urine

HPLC/UV

5 ng/mL

Active

Creamide

Plasma

LC-MS/MS

0.1 µg/mL

Active

Cycloserine

Plasma

LC-MS/MS

0.3 µg/mL

Active

Dapoxetine

Plasma

LC-MS/MS

1 ng/mL

Active

Darunavir

Plasma

LC-MS/MS

50 ng/mL

Active

Dasatinib

Plasma

LC-MS/MS

1 ng/mL

Active

Dexamethasone

Urine

HPLC/UV

1 ng/mL

Active

Docetacel

Plasma

LC-MS/MS

2 ng/mL

Active

Dopamine

Plasma

Urine

HPLC/ED

0.35 ng/mL

Active

Doxorubicin

Plasma

Tissue

LC-MS/MS

0.5 ng/mL

Active

Dutasteride /

Tamsulosin

Plasma

LC-MS/MS

0.1/

0.2 ng/mL

Active

Efavirenz

Plasma

LC-MS/MS

100 ng/mL

Active

Emtricitabine

Plasma

LC-MS/MS

20 ng/mL

Active

Emtricitabine /

Tenofovir

Plasma

LC-MS/MS

10 ng/mL

4 ng/mL

Active

Entecavir

Plasma

LC-MS/MS

0.1 ng/mL

 

Active

Epinephrine

Plasma

Urine

HPLC/ED

0.2 ng/mL

Active

Eplerenone

Plasma

LC-MS/MS

25  ng/mL

Active

Eremomycin

Plasma

LC-MS/MS

50 ng/mL

Active

Etoricoxib

Plasma

LC-MS/MS

-

Development

Fexofenadine

Plasma

LC-MS/MS

1 ng/mL

Active

Finasteride

Plasma

LC-MS/MS

-

Development

Fingolimod ( FTY720 )/

Fingolimod phosphate ( FTY720-P)

Blood

LC-MS/MS

50 pg/mL

70 pg/mL

Active

Fosfomycin

Plasma

LC-MS/MS

-

 

Gliclazide

Plasma

LC-MS/MS

20 ng/mL

Active

Homovanillic acid

Urine

HPLC/ED

10 ng/mL

Active

Ibuprofen

Plasma

LC-MS/MS

200 ng/mL

Active

Imatinib

Plasma

LC-MS/MS

5 ng/mL

Active

Ketorolac

Plasma

LC-MS/MS

10 ng/mL

Active

Kynurenine

Plasma

HPLC/UV

10 ng/mL

Inactive

Kynurenic acid

Plasma

HPLC/UV

20 ng/mL

Inactive

Lenalidomide

Plasma

LC-MS/MS

1 ng/mL

Active

Levetiracetam

Plasma

LC-MS/MS

200 ng/mL

Active

Levofloxacin

Plasma

LC-MS/MS

250 ng/mL

Active

Lidocaine

Plasma

LC-MS/MS

1 ng/mL

Active

Linezolid

Plasma

LC-MS/MS

100 ng/mL

Active

Lipoic acid

Plasma

LC-MS/MS

5 ng/mL

Active

Lisinopril

Plasma

LC-MS/MS

5 ng/mL

Active

Losartan

Plasma

LC-MS/MS

5 ng/mL

Active

Irbesartan

Plasma

LC-MS/MS

5 ng/mL

Active

Marcaine

Plasma

Tissue

LC-MS/MS HPLC/UV

1 ng/mL

Active

Mebeverin Acid/

o-desmethyl mebeverine acid

Plasma

LC-MS/MS

1 ng/mL

5 ng/mL

Active

Meloxicam

Plasma

 

LC-MS/MS

10  ng/mL

Active

Melphalan

Plasma

Tissue

LC-MS/MS

0.3 ng/mL

Active

Memantine

Plasma

LC-MS/MS

0.3 ng/mL

Active

Metanephrine

Urine

HPLC/ED

10 ng/mL

Active

Metoprolol

Plasma

LC-MS/MS

0.1 ng/mL

Active

Mexidol (Emoxypine)

Plasma

LC-MS/MS

0.5 ng/mL

Active

Mildronate

Plasma

LC-MS/MS

50 ng/mL

Active

4-Methylaminoantipyrine (Metamizole metabolite)

Plasma

LC-MS/MS

100  ng/mL

Active

Mitomicyn C

Plasma

Tissue

LC-MS/MS

0.6 ng/mL

Active

Mitoxantrone

Plasma

Tissue

LC-MS/MS

5 ng/mL

Inactive

Montelukast/

Cetirizine

Plasma

LC-MS/MS

10 ng/mL

1 ng/mL

Active

Moxifloxacin

Plasma

LC-MS

2 ng/mL

Active

Naftidrofuryl

Plasma

LC-MS/MS

10  ng/mL

Active

Naloxone

Plasma

LC-MS/MS

80 pg/mL

Active

Naltrexone

Plasma

LC-MS/MS

150 pg/mL

Active

Nevirapine

Plasma

LC-MS

80 ng/mL

Active

Nifedipine/

Lidocaine

Plasma

LC-MS/MS

0.5 ng/mL

1 ng/mL

Active

Nilotinib

Plasma

LC-MS/MS

2 ng/mL

Active

Nimesulide

Plasma

LC-MS/MS

20 ng/mL

Active

Norepinephrine

Plasma

Urine

HPLC/ED

0.2 ng/mL

Active

Normetanephrine

Urine

HPLC/ED

5 ng/mL

Active

Oxybutynin

Plasma

Tissue

LC-MS/MS

0.5 ng/mL

Active

Oseltamivir carboxylate

Plasma

LC-MS/MS

2 ng/mL

Active

PAS (4-Aminosalicylic acid)

Plasma

LC-MS/MS

50  ng/mL

Active

Penciclovir

Plasma

LC-MS/MS

50 ng/mL

Active

Perindopril /

Perindoprilat

Plasma

LC-MS/MS

0.4 ng/mL

Active

Perindoprilat /

Indapamide

Plasma

LC-MS/MS

0.4 ng/mL

0.3 ng/mL

Active

Phenibut

Plasma

LC-MS/MS

10 ng/mL

Active

Phenylephrine

Plasma

LC-MS/MS

-

Development

Pregabalin

Plasma

LC-MS/MS

50 ng/mL

Active

Rabeprazole

Plasma

LC-MS

2 ng/mL

Active

Ranolazine

Plasma

LC-MS/MS

5 ng/mL

Active

Ramipril /

Ramiprilat

Plasma

LC-MS/MS

0.2 ng/mL

0.5 ng/mL

Active

Ritonavir

Plasma

LC-MS/MS

5 ng/mL

Active

Rivaroxaban

Plasma

LC-MS/MS

0.5 ng/mL

Active

Rhein (Diacerein)

Plasma

HPLC/UV

100 ng/mL

Active

Ropinipole

Plasma

LC-MS/MS

10 pg/mL

Active

Rosuvastatin

Plasma

LC-MS/MS

0.2 ng/mL

Active

Salbutamol

Plasma

LC-MS/MS

0.2 ng/mL

Active

Serotonin

Plasma

HPLC/UV

10 ng/mL

Active

Sildenafil

Plasma

LC-MS

5 ng/mL

Active

Sildenafil

Plasma

LC-MS/MS

1 ng/mL

Active

Simvastatine / Simvastatin acid

Plasma

LC-MS/MS

-

Development

Spironolactone /

Canrenone

Plasma

LC-MS/MS

2 ng/mL

2 ng/mL

Active

Stavudine

Plasma

HPLC/UV

30 ng/mL

Active

Succinic acid

Plasma

LC-MS/MS

0.1 µg/mL

Active

Tacrolimus

Blood

LC-MS/MS

0.5 ng/mL

0.1 ng/mL

Active

Active

Telmisartan

Plasma

LC-MS/MS

3 ng/mL

Active

Telmisartan/

Hydrochlorothiazide

Plasma

LC-MS/MS

3 ng/mL

1 ng/mL

Active

Tenofovir

Plasma

LC-MS/MS

4 ng/mL

Active

Terizidone

Plasma

LC-MS/MS

0.3 µg/mL

Active

Thyroxine (T4)

Serum

LC-MS/MS

30 ng/mL

Active

Troventol

Plasma

LC-MS/MS

35 pg/mL

Active

Troxerutin

Plasma

LC-MS/MS

-

Development

Tryptophan

Plasma

HPLC/UV

10 ng/mL

Active

Quetiapine

Plasma

LC-MS/MS

1  ng/mL

Active

Valsartan

Plasma

LC-MS/MS

10 ng/mL

Active

Vanillyl mandelic acid

Urine

HPLC/UV

10 ng/mL

Active

Vinblastine

Plasma

Tissue

LC-MS/MS HPLC/UV

1 ng/mL

Active

Voriconazole

Plasma

LC-MS

20 ng/mL

Active

Zidovudine

Plasma

LC-MS/MS

40 ng/mL

Active

Zidovudine /

Lamivudine

Plasma

LC-MS/MS

30 ng/mL

25 ng/mL

Active

The list of validated methods

Contacts

Our adress:


195220, Saint-Petersburg,
Gzhatskaya st.27, office 240

Phone.:

+7 (812) 294-82-04

Fax:

+7 (812) 294-82-04

E-mail:

info@csuas.ru
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