j res pharm

Marmara Pharmaceutical Journal

1309-0801

Marmara University

Health Care Administration

Sağlık Kurumları Yönetimi

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

Atila Karaca

Sakine

Yeniceli Uğur

Duygu

12 01 2017

21 4 931 937 07 07 2017 08 02 2017

1985

Marmara Pharmaceutical Journal

A new, rapid and simple HPLC method for determination ofLurasidone in its tablets has been developed and validated.Lurasidone and internal standard (Chlorpromazine) wasseparated on a Zorbax XDB C8 column (4.6 x 50 mm, 3.5μm particle size) set at 40°C and quantified by ultravioletdetection at 230 nm. The mobile phase was phosphate buffer(pH:3, 20 mM): acetonitrile: methanol (55:10:35, v/v/v) with aflow rate of 1.2 mL/min. Retention times of Chlorpromazineand Lurasidone was 4.73 and 6.89 minutes, respectively. Themethod was found linear over the concentration range of 0.5-50μg/mL Lurasidone. Limit of detection and quantification valuesfor Lurasidone was 0.1295 and 0.4317 μg/mL, respectively. Theintra- and inter day precisions were less than 2% and the meanrecoveries were 100.32%, which indicated that the methodwas precise and accurate. All other validation parameters werefound within acceptable limits. The validated method has beensuccessfully applied for determination of Lurasidone in itstablets.Keywords:

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

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