METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF LURASIDONE BY RP-HPLC AND HPTLC

Rapilane Krishnamurthi Sangeetha*

ABSTRACT

Lurasidone is an atypical antipsychotic of benzisothiazol class used in the treatment of schizophrenia. The drug is not official in any pharmacopoeia and hence validated analytical methods are needed for its determination in tablet dosage form. The HPTLC method was developed with a mobile phase of methanol: ethyl acetate: toluene in the ratio of 1:1:8 v/v/v with a Rf value of 0.68 at a wavelength of 230 nm. Linearity was found over the concentration range of 5-80 ng/spot with a correlation coefficient of 0.99421. LOD and LOQ was found to be 1ng/spot and 5ng/spot. Recovery studies at 50% and 100% levels were between 97.9 to 101.11%. The HPLC method was developed with a mobile phase system of ammonium acetate(pH 5.5):
acetonitrile: methanol in the ratio of 35:30:35, v/v/v at a retention time of 7.39 minute and flow rate of 1ml/min. Linearity of lurasidone was found over the range of 0.1-4.5μg/ml. LOD and LOQ values were found to be 0.001 and 0.005μg/ml. Recovery studies at 50% and 100% levels were between 98 to 100.6%. Both the methods were validated as per the ICH guidelines. These methods can be employed for the routine analysis of lurasidone in tablet dosage form.

Keywords: Chromatography, HPLC, HPTLC, Lurasidone.