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Atypical Neuroleptics in Plasma / Serum | On-Line Analysis, Complete Kit, Order No. 40 000

 

The drugs olanzapine, clozapine, quetiapine, risperidone, and paliperidone (= 9-OH-risperidone) belong to the class of the so called “atypical” neuroleptics and are used for the treatment of schizophrenia. Co-medication, smoking, caffeine and food are factors that extensively influence their metabolism and thus lead to a high intra- and interindividual variability of drug concentrations in blood. In order to avoid severe side effects by overdosing and to ensure an optimal therapeutic effect, therapeutic drug monitoring (TDM) especially for olanzapine and clozapine is „strongly recommended“*. Here, the complete kit of RECIPE represents a fully automated, robust on-line technique, that allows to inject the samples directly (i.e. without manual sample preparation) into the HPLC system.

*Recommendations for TDM according to the consensus guidelines of the AGNP-TDM Expert Group, Germany, 2005: Olanzapine, clozapine: „strongly recommended“; risperidon plus 9-OH-risperidone: „recommended“, quetiapine: „useful“.

  
  • Fully automatic method


  • On-line sample preparation


  • Injection interval: 20 / 22 min


  • 100 % recovery


Test Data

  

HPLC Parameters
Linearity: 5 - 1000 µg/l (Olz)
  6 - 5000 µg/l (Clz)
  10 - 1000 µg/l (D-Olz)
  4 - 5000 µg/l (D-Clz)
  10 - 2000 µg/l (Qtp)
  1 - 200 (Rsp)
  1 - 200 (Plp)
Recovery: 100 %
Lower detection limit 2.0 (Olz), 3.6 (D-Olz),
(µg/l): 2.2 (Clz), 1.6 (D-Clz),
  3.6 (Qtp), 0.4 (Rsp), 0.4 (Plp)
Lower determination limit 5.4 (Olz), 9.9 (D-Olz),
(µg/l): 5.9 (Clz), 4.3 (D-Clz),
  9.9 (Qtp), 1.0 (Rsp), 1.1 (Plp)
Intraassay precision: 0.8 % (Olz), 1.1 (D-Olz),
  0.9 % (Clz), 0.8 % (D-Clz),
  0.8 % (Qtp), 0.9 % (Rsp), 1.3 % (Plp)
Interassay precision: 1.4 % (Olz), 2.1 % (D-Olz),
  1.3 % (Clz), 1.9 % (D-Clz),
  2.4 % (Qtp), 4.9 % (Rsp), 2.4 % (Plp)
 
A: Olz, D-Olz, Clz, D-Clz, Qtp
B: Rsp, Plp
   
Pump 1:
(SPE-Buffer)		 isocratic pump,
flow rates: 0.5 / 1.0 ml/min
Pump 2:
(Mobile Phase)		 isocratic pump,
flow rate:
A: 1.3 ml/min
B: 1.0 ml/min
Injection volume: A: 250 µl
B: 750 µl
Injection interval: A: 22 min
B: 20 min
UV-Detector: A: 254 nm
B: 280 nm
HPLC-Thermostat: 30°C
   
System configuration

 

Sample Preparation

sample preparation

 

Chromatograms
Chromatogram of the plasma calibrator, order no. 40013
(+ 20 µl Internal Standard IS per ml sample, order no. 40012)		 Chromatogram of the plasma calibrator, order no. 40113 (+ 10 µl Internal Standard IS per ml sample, order no. 40012)
 
Desmethylolanzapine (D-Olz): 9.51 min, Olanzapine (Olz): 11.15 min, Desmethylclozapine (D-Clz): 12.27 min, Internal Standard: 14.43 min, Clozapine (Clz): 18.55 min, Quetiapine (Qtp): 20.25 min  
Paliperidone (Plp): 10.47 min, Risperidone (Rsp): 11.68 min, Internal Standard IS: 16.65 min


Atypical Neuroleptics in Plasma / Serum - On-Line Analysis, Complete Kit, Order No. 40 000

Ordering Information

Order No. Description Quantity
40000  ClinRep® Complete Kit for Atypical Neuroleptics in Plasma / Serum - on-line for 100 assays 1 pce. 
 
  Kit Components (order no. 40000):  
40009 SPE-Buffer 1000 ml
within the kit: 2 x order no. 40009
40010 Mobile Phase 2000 ml
within the kit: 2 x order no. 40010
40013 Plasma Calibrator, lyophil. 5 x 3 ml
  Manual 1 pce.
  Quick Reference 1 pce.
 
  Optional Components:  
40014 Test Solution 5 x 2 ml
40012 IS Internal Standard 2 ml
40114 Test Solution for Risperidone and Paliperidone 15 ml
40113 Plasma Calibrator, lyophil., for Risperidone and Paliperidone 5 x 5 ml
     
  Start Accessories:  
40030 Analytical Column with test chromatogram 1 pce.
40031 SPE-Column 1 pce.
40032 Guard Column Holder incl. 1 Guard Column 1 pce.
40033 Guard Column 5 pcs.
FK7400 Inline Filter (stainless steel sieve, free of dead volume) 1 pce.
 
  ClinChek® Controls:  
40080 Plasma Control, lyophil., Level I 10 x 3 ml
40081 Plasma Control, lyophil., Level II 10 x 3 ml
40082 Plasma Control, lyophil., Level I, II 2 x 5 x 3 ml
40180 Plasma Control, lyophil., for Risperidone and Paliperidone, Level I 10 x 5 ml
40181 Plasma Control, lyophil., for Risperidone and Paliperidone, Level II 10 x 5 ml
40182 Plasma Control, lyophil., for Risperidone and Paliperidone, Level I, II 2 x 5 x 5 ml

 

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