A NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-UPLC ASSAY FOR THE DETERMINATION OF LURASIDONE HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORMS.
Tirukkovalluri Siva Rao*, Tene Sivaganesh, Kommula Ramasrinivas, Uppalapu Sesham Raju, Pinninti Sateesh Kumar
ABSTRACT
Method development, validation and stability indicating RP-UPLC method for Assay determination of LurasidoneHcl in pharmaceutical products. This method has high degree of performance to separation and quantification of Lurasidone even in the presence of its impurities. This efficient Separation can be achieved by using new Waters Acquity CSH Phenyl hexyl with dimensions (100mm x 2.1 mm, 1.7μm). The buffer used in this method KH2PO4 at pH 2.5 and Acetonitrile in the ratio of (65:35 v/v) with a flow rate of 0.5 ml/min and the absorbance was monitored at 230 nm. The total run time was 3.0 min. The correlation coefficient of the method shows good linear relationship with 0.9999. The limit of detection and quantification are determined for LurasidoneHCl 0.01μg/ml and 0.03μg/ml. The signal to noise ratio has been observed 7 and 12 for LOD & LOQ respectively. The precision of the method %RSD is less than 0.40% and the % recovery of LurasidoneHCl is between 99.5 – 100.1 %.When the drug is subjected to different stress conditions and the resulting degradation products obtained were not interfere during the determination of LurasidoneHCl.
Keywords: Lurasidone HCl, RP-UPLC, Method development, Validation, Stability-indicating.
[Full Text Article]
[Download Certificate]
Impact Factor : 8.181 
