Development of a validated high-performance liquid chromatographic method for the determination of Lurasidone in pharmaceuticals

Yıl 2017, Cilt: 21 Sayı: 4, 931 - 937, 01.12.2017

Sakine Atila Karaca Duygu Yeniceli Uğur

Öz

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:

Anahtar Kelimeler

Lurasidone; high performance liquid chromatography; tablet analysis; validation.

Kaynakça

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