Editor-in-Chief
Hatice Kübra Elçioğlu
Vice Editors
Levent Kabasakal
Esra Tatar
Online ISSN
2630-6344
Publisher
Marmara University
Frequency
Bimonthly (Six issues / year)
Abbreviation
J.Res.Pharm.
Former Name
Marmara Pharmaceutical Journal
Marmara Pharmaceutical Journal
2017 , Vol 21 , Issue 4
Development of a validated high-performance liquid chromatographic method for the determination of Lurasidone in pharmaceuticals
1Department of Analytical Chemistry, Faculty of Pharmacy, Anadolu University, 26470 Eskisehir, Turkey
DOI :
10.12991/mpj.2017.32
A new, rapid and simple HPLC method for determination of
Lurasidone in its tablets has been developed and validated.
Lurasidone and internal standard (Chlorpromazine) was
separated on a Zorbax XDB C8 column (4.6 x 50 mm, 3.5
μm particle size) set at 40°C and quantified by ultraviolet
detection at 230 nm. The mobile phase was phosphate buffer
(pH:3, 20 mM): acetonitrile: methanol (55:10:35, v/v/v) with a
flow rate of 1.2 mL/min. Retention times of Chlorpromazine
and Lurasidone was 4.73 and 6.89 minutes, respectively. The
method was found linear over the concentration range of 0.5-50 μg/mL Lurasidone. Limit of detection and quantification values
for Lurasidone was 0.1295 and 0.4317 μg/mL, respectively. The
intra- and inter day precisions were less than 2% and the mean
recoveries were 100.32%, which indicated that the method
was precise and accurate. All other validation parameters were
found within acceptable limits. The validated method has been
successfully applied for determination of Lurasidone in its
tablets.
Keywords :
Lurasidone; high performance liquid chromatography; tablet analysis; validation