METHOD OF ANALYSIS

METHOD OF ANALYSIS

METHOD OF ANALYSIS

 

           Bioanalysis

All bioanalytical projects are approached with a focus on excellence,efficiency  and speed. Our goal is to consistently provide the best possible analysis in the shortest time while maintaining full compliance with all regulatory requirements.

            BIOANALYTICAL SERVICES

·        Method development.

·        Method validation.

 

        Method Transfer

·        HPLC Analysis of drug and metabolites in biological fluids from clinical trials & bioequivalence.

·        LC/MS/MS Analysis of drug and metabolites in biological fluids from clinical trials & bioequivalence.

 

 

         Services Focus

          Analytical Laboratory features the latest bioanalysis equipment and technologies and a   specialized Method Development Group of scientists committed to developing methods with the lowest LLOQ and very rapid turnaround times. We offer non-exclusive methods for drugs in all major therapeutic areas, ready to be used with a short lead time to analyze drugs and metabolites in biological fluids.

DRC List of Validated  Analytical Methods

Range Dose Instrument

 Drug Name

  (Generic)

 Ser. No.
15-150µg/ml 100mg LC-MS/MS Pregabalin 100mg Hard Gelatin Capsule 1
25-600µg/ml 500mg
(10ng/ml)		 LC-MS/MS Azithromycin  500 mg Film Coated Tablets    2
90-900µg/ml 750mg
(100ng/ml)		 HPLC-UV Ciprofloxacin 750mg  Film Coated Tablets 3
60-1200  µg/ml 1gm
(1µg/ml)		 HPLC-Photodiode Array Cefadroxil 1gm Tablets 4
6-600µg/ml 500mg HPLC-UV
Diode Array		 Amoxicillin 500mg/Flucloxacillin 500mg Film Coated Tablets 5
0.75-13.5µg/ml 2.5mg
(1µg/ml)		 LC-MS/MS Desloratadine 5mg Film Coated Tablet 6
7.5-270µg/ml 180mg
(10µg/ml)		 LC-MS/MS Fexofenadine 180mg Film Coated Tablets 7
0.1-1µg/ml 1mg HPLC-UV Gramocef 1mg Film Coated Tablets 8
1-20µg/ml 10mg LC-MS/MS Memantine 10mg Film Coated Tablets 10
0.3-6µ/ml 2.5mg HPLC-UV Nebivelol 2.5mg scored tablets 11
25-250µg/ml 200mg HPLC-UV Nifuroxazide 200mg Hard Gelatin Capsule 12
15-150µg/ml 100mg LC-MS/MS Pregabalin 100mg Hard Gelatin Capsule 13
  25-200µg/ml 150mg LC-MS/MS Pregabalin 150mg Hard Gelatin Capsule 14
1-12µg/ml 10mg HPLC-UV Rosuvastatin  5mg Film Coated Tablets 15
1-12µg/ml 5mg HPLC-UV Rosuvastatin 10mg Film Coated Tablets 16
0.6-6µg/ml 5mg HPLC-UV Solfenacin 5mg Film Coated Tablets 17
60-600µg/ml 500mg
(100µg/ml)		 LC-MS/MS Tranexamic acid 500mg Film Coated Tablet 18
10-140µg/ml 100mg
(40µg/ml)		 HPLC-Photo Diode Array Lamotrigine 100 mg Tablet 19
15-150 µg/ml 100mg
(1.0ng/ml)		 LC-MS/MS Sildenafil 100mg Film Coated Tablets 20
20-200µg/ml 6mg/25mg
(50ng/ml)		 LC-MS/MS Topiramate 100mg Film Coated Tablet 21

 

 DRC List of Validated Bio-Analytical Methods
Range   Dose
(LLOQ)		 Anticoagulant Matrix Instrument

      Drug Name

( Generic )                           

Ser. No 
  Location : Egypt
1-100 ng/ml 70mg
0.74ng/ml) )		 K2EDTA Human Plasma LC-MS/MS Alendronate Sodium 70 mg Tablet 1
1000-10 ng/ml 500mg K2EDTA Human Plasma LC-MS/MS Azithromycin  500 mg Film Coated Tablets    2
50-5000 ng/ml 100mg
(50ng/ml)		 K2EDTA Human Plasma LC-MS/MS Atomoxetine100mg Hard gelatin Capsule 3
0.01-0.8 ng/ml 2.5mg
0.01ng/ml) )		 K2EDTA Human Plasma LC-MS/MS Bromocriptine
2.5 mg Tablet		 4
100-1000 ng/ml 750mg
100ng/ml) )		 K2EDTA Human Plasma HPLC-UV Ciprofloxacin 750mg  Film Coated Tablets 5
1-40  µg/ml 1gm
(1µg/ml)		 K2EDTA Human Plasma HPLC-Photodiode Array Cefadroxil 1gm Tablet 6
0.1--40 ng/ml 5mg
1 ng/ml) )		 K2EDTA Human Plasma LC-MS/MS Desloratadine 5mg Film Coated Tablet 7
0.5-30 ng/ml 10mg
0.5 ng/ml) )		 K2EDTA Human Plasma LC-MS/MS Domperidone 10 mg Film Coated Tablet 8
0.5-50 ng/ml 1mg
(0.5ng/ml)		 K2EDTA Human Plasma LC-MS/MS Doxazosin Mesylate 1 mg Tablet 9
0.025-2 µg/ml
0.1-20 µg/ml		 50mg/500mg
0.02ug/ml )
0.076ug/ml)		 K2EDTA Human Plasma HPLC-UV Diclofenac Potassium 50 mg / Methocarbamol 500 mg Film Coated Tablet 10
0.5-100 ng/ml 20mg
(0.5ng/ml)		 K2EDTA Human Plasma LC-MS/MS Enalapril 20 mg Tablet 11
10-2000 ng/ml 180mg
(10 ng/ml)		 K2EDTA Human Plasma LC-MS/MS Fexofenadine 180 mg Film Coated Tablet 12
0.5-300 ng/ml 40mg/5mg
0.5 ng/ml) )		 K2EDTA Human Plasma LC-MS/MS Famotidine 40 mg/ 5ml Powder for Oral Reconstitution 13
0.1-10 µg/ml 600mg
0.1ug/ml) )		 K2EDTA Human Plasma LC-MS/MS Gabapentin 600 mg Film Coated Tablet 14
2.5-250 ng/ml 3mg
(2.5 ng/ml)		 K2EDTA Human Plasma LC-MS/MS Glimipride 3 mg Tablet 15
1-60 µg/ml 400mg
1ug/ml) )		 K2EDTA Human Plasma HPLC-UV Ibuprofen 400mg  Film Coated Tablet 16
0.005-10 µg/ml 200mg
(0.005µg/ml)		 K2EDTA Human Plasma HPLC-Photo Diode Array Lamotrigine 200 mg Tablet 17
5-500 ng/ml 5mg
(5ng/ml)		 K2EDTA Human Plasma LC-MS/MS Levocetrzine 5mg Film coated Tablet 18
0.1-10 µg/ml 100mg/5ml
(0.1 µg/ml)		 K2EDTA Human Plasma HPLC-UV Linzolid 100mg/5ml Granules for Oral Suspension 19
0.1-15 µg/ml 750mg
0.1µg/ml) )		 K2EDTA Human Plasma HPLC-UV Levofloxacin 750 mg Film Coated Tablet 20
0.1-20 ng/ml 10mg
(0.1ng/ml)		 K2EDTA Human Plasma LC-MS/MS Memantine Hydrochloride 10 mg Tablet 22
0.2-8 µg/ml 400mg
0.2µg/ml) )		 K2EDTA Human Plasma HPLC- Photo Diode Array Moxifloxacin 400 mg Film Coated Tablet 23
0.001-1 µg/ml 750mg
0.001ug/ml) )		 K2EDTA Human Plasma LC-MS/MS Nicotinic Acid
 750 mg Tablet		 24
1-20 ng/ml
1-45 ng/ml		 6mg /25mg
(0.1ng/ml)		 K2EDTA Human Plasma LC-MS/MS Olanzapine 6 mg / fluoxetine 25 mg Capsule 25
0.083 -10 µg/ml 400mg
(0.083µg/ml)		 K2EDTA Human Plasma HPLC-UV Ofloxacin 400 mg Film Coated Tablet 26
10-2000 ng/ml 40mg/100mg
(10 ng/ml)		 K2EDTA Human Plasma LC-MS/MS Omeprazole 40/100mg  Hard gelatin Capsule  27