Volume : V, Issue : V, May - 2015

APPROACH TO BIOANALYTICAL METHOD DEVELOPMENT BY DRY BLOOD SPOT AND LC–MS/MS USING SAQUINAVIR DRUG AS AN ANALYTE

Vijay Kumar Raina, Wishu Shrivastava, Akena Venkatesham, Yuan Song, P. K. Patel

Abstract :

 Dry blood spot (DBS) is amicro sampling techniqueto collectblood samples on a suitable paperto predominantly screen medical disorders by analyzing the dried blood spots using different analytical techniques. In the past few years DBS has gained significancein drug development due to its ethical and logistical advantages over conventional sampling in pharmacokinetic (PK), toxicokinetic(TK) and therapeutic drug monitoring (TDM)  studies. Bioanalysis of DBS samplesobtained from PK, TK and TDM studiesrequire sensitive and reproducible bioanalytical method to accurately measure theconcentration of drugs in these samples. DBS method development is quite  challenging, especially for low sensitivity assays. A comprehensive approach was adoptedthat resulted in a sensitive  and a reproducible DBS–LC–MS/MS method for a therapeutic drug. The reportedmethod provides an insight into DBS  methoddevelopment;same approach can be usefulfor a wide range of drugs of similar nature. Saquinavir drug was used as an analyte to develop a DBS bioanalytical method by LC–MS/MS quantitation. Sample  preparation parameters related toDBS card selection, sample spotting, sample drying,sample punching, suitability of  extraction solvent and sample mixingwere evaluated thoroughly. Agilent DMS card gave optimalresults than other DBS  cards tested during the optimization (for example: DMPK–A, B and C and Tomtec–200, 300and 400).The method demonstrated 200 fold linearity from 5.056 ng/mL to 10062.500 ng/mL. The mean recovery of Saquinavir was 41.6%. The  overall precision (% CV) and accuracy (% nominal) of the method was within ± 15% and 85.0% to 115.0% respectively.  The method can beapplied to routine bioanalysis for Saquinavir.

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Article: Download PDF   DOI : 10.36106/ijar  

Cite This Article:

Vijay Kumar Raina, Wishu Shrivastava, Akena Venkatesham,Yuan Song, P.K. Patel APPROACH TO BIOANALYTICAL METHOD DEVELOPMENT BY DRY BLOOD SPOT AND LC–MS/MS USING SAQUINAVIR DRUG AS AN ANALYTE Indian Journal of Applied Research, Vol.5, Issue : 5 May 2015

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