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Inventi Impact - Biomedical Analysis

Articles

  • Inventi:pba/20297/16
    BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF LURASIDONE HYDROCHLORIDE USING RP-HPLC IN RAT PLASMA
    Dinesh C Sancheti*, Manoj C Kamble, Rahul R Mane

    A simple, precise, rapid and sensitive bioanalytical RP-HPLC method was developed for estimation of lurasidone HCl in rat plasma. The work carried out using Purospher® STAR Hibar® 250 mm C18 (4.6 mm × 25 cm, packed with 5 particles) column equipped with Shimadzu LC-2010 CHT HPLC system with mobile phase containing acetonitrile: methanol: 0.01M sodium phosphate monobasic buffer (pH 4) in the ratio 60:30:10 v/v (1.2 ml/min) and detection wavelength 230 nm. The retention time of lurasidone HCl was found to be 7.81 min. The developed bioanalytical method was found to be linear in concentration range of 2.27-13.63 ng/μl (R2 =0.9778) with LLOQ of 2.27 ng/μl and ULOQ of 13.63 ng/μl. The precision study revealed that the percentage cumulative variation was within acceptable limit and accuracy study showed the value of mean percent recovery between 87.06-103.39 %. The lurasidone HCl was stable in rat plasma at different storage conditions. The validation parameters of the method met the acceptance criteria. Sufficient stability at LQC and HQC was shown to allow for completion of sample analysis in clinical trials. From the results, it was concluded that developed bioanalytical method can be used for routine analysis of lurasidone HCl.

    How to Cite this Article
    Dinesh C Sancheti, Manoj C Kamble, Rahul R Mane. Bioanalytical Method Development and Validation for Estimation of Lurasidone Hydrochloride using RP-HPLC in Rat Plasma. Inventi Impact: Biomedical Analysis, 2017(1):1-5, 2017.
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