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You are here: Home / Bioequivalence Studies / Bioanalytical Methods

Bioanalytical Methods

Method validation is one of the most crucial components in any regulatory submission. We can conduct method validations for various analytical methods; from simple UV based assays to complex chromatographic methods for impurities and related substances. Our validation protocols and reports are based on globally acceptable guidelines like ICH/FDA/USP guidelines and cover various parameters like

a. Accuracy b. Precision c. Linearity d. Range e. Specificity f. Limit of detection g. Limit of quantification h. Robustness i. Stability in biological matrix

Auriga’s Bio-Analytical wing is our forte which is well equipped with state of the art equipments. Some of the main facilities of the bio-analytical laboratory include chromatography laboratory with HPLCs and GCs, LC-MS/ MS laboratory, ICP- MS laboratory, GC- MS laboratory, Cold room and deep freezer for sample storage.

A number of validated analytical methods available in the lab and are constantly work is going on more and more methods in the pipeline. Diverse array of analytical techniques available in our facility allow us to quickly develop and validate methods for even the most challenging molecules. This has never been a bottleneck in our services.

In house methods developed by our bioanalytical team is listed below

List of AMV
S. No. Analyte LLOQ Unit Matrix Instruments
1 Curcumin 10 ng/ml Plasma LC/MS/MS
2 Diclofenac sodium 20 ng/ml Plasma LC/MS/MS
3 Ibuprofen 500 ng/ml Plasma LC/MS/MS
4 Metoprolol 10 ng/ml Plasma LC/MS/MS
5 Ofloxacin 200 ng/ml Plasma LC/MS/MS
6 Artemether + Lumefantrine 20.0 & 250.0 ng/ml Plasma LC/MS/MS
7 Carbamazepine 10 ng/ml Plasma LC/MS/MS
8 Levonorgestrel 0.25 ng/ml Plasma LC/MS/MS
9 Rabeprazole 20.35 ng/ml Plasma LC/MS/MS
10 Cefixime + Dicloxacillin 200.0 & 500.0 ng/ml Plasma LC/MS/MS
11 Metformin 171.12 ng/ml Plasma LC/MS/MS
12 Oxcarbazepine and MHD (metabolite) 24.84 & 25.74 ng/ml Plasma LC/MS/MS
13 Clopidogreal 0.141 ng/ml Plasma LC/MS/MS
14 Fluconazole 23.3 ng/ml Plasma LC/MS/MS
15 Theophylline 533.9 ng/ml Plasma LC/MS/MS
16 Bisoprolol 10 ng/ml Plasma LC/MS/MS
17 Atenolol 10.08  to 1557.54 ng/ml Plasma LC/MS/MS
18 Ambroxol 5.03 ng/ml Plasma LC/MS/MS
19 Losartan & Losartan Carboxylic Acid 5.35 & 10.49 ng/ml Plasma LC/MS/MS
20 Furosemide 15.5 ng/ml Plasma LC/MS/MS
21 Ondensetron 1.02 ng/ml Plasma LC/MS/MS
22 Azithromycin 2.45 ng/ml Plasma LC/MS/MS
23 Meloxicam 0.075 ng/ml Plasma LC/MS/MS
24 Metformin + Glimepiride 25.45 & 7.42 ng/ml Plasma LC/MS/MS
25 Cefpodoxime + Dicloxacillin 41.77 & 324.60 ng/ml Plasma LC/MS/MS
26 Metformin+ Glimepiride+ Pioglitazone 25.45, 7.42 &17.94 ng/ml Plasma LC/MS/MS
27 Glimepiride 7.42 ng/ml Plasma LC/MS/MS
28 Rosuvastatin + Finofibrate 2.08 & 80.74 ng/ml Plasma LC/MS/MS
29 Memantine 2.02 ng/ml Plasma LC/MS/MS
30 Itraconazole 5.61 ng/ml Plasma LC/MS/MS
31 Aceclofenac + Thiocolchicoside 514.65 & 1.79 ng/ml Plasma LC/MS/MS
32 Cefixime + Ofloxacin 201.1 & 205.2 ng/ml Plasma LC/MS/MS
33 Telmisartan 5.16 ng/ml Plasma LC/MS/MS
34 Gabapentine 412.39 ng/ml Plasma LC/MS/MS
35 Tranexamic Acid 5.03 ng/ml Plasma LC/MS/MS
36 Prochlorperazine 5.03 ng/ml Plasma LC/MS/MS
37 Pregabalin SR 300 mg and 50.09 ng/ml Plasma LC/MS/MS
Methylcobalamin 1500 mcg Tablet
38 Pregabalin 50.01 ng/ml Plasma LC/MS/MS
39 Cefuroxime Axetil 417.14 ng/ml Plasma LC/MS/MS
40 Aspirin and Rosuvastatin 51.81 & 2.08 ng/ml Plasma LC/MS/MS
41 Levosulpiride 10.27 ng/ml Plasma LC/MS/MS
42 Sildenafil & N-desmethyl sildenafil 15.60 & 15.54 ng/ml Plasma LC/MS/MS
43 Atorvastatin, 2-AT, 4-AT 1.99, 1.48 & 0.24 ng/ml Plasma LC/MS/MS
44 Pantoprazole 25.23 ng/ml Plasma LC/MS/MS
45 Amoxicillin Suspension 0.22 µg/ml Plasma LC/MS/MS
46 Fexofenadine and Montelukast 11.31 & 55.19 ng/ml Plasma LC/MS/MS
47 (S)-Amlodipine 0.77 ng/ml Plasma LC/MS/MS
48 Donepezil 5.06 ng/ml Plasma LC/MS/MS
49 Lornoxicam 21.51 ng/ml Plasma LC/MS/MS
50 Budesonide Nebuliser Suspension 0.0465 ng/ml Plasma LC/MS/MS
51 Dapoxetine 18.64 ng/ml Plasma LC/MS/MS
52 Albendazole 15.16 ng/ml Plasma LC/MS/MS

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Auriga Research Pvt. Ltd. (A Contract Research Organization)
3/15 Kirti Nagar Industrial Area
New Delhi
India 110015
e-mail - [email protected]
Telephone - +91 11 45754546

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