Article Details

RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF LURASIDONE HYDROCHLORIDE IN BULK AND TABLET FORM

K. Vijaya Sri a*, M.Shiva Kumar a and A. Sravani a

a Department of Pharmaceutical Analysis,
Malla Reddy College of Pharmacy, (Affiliated to Osmania University),
Maisammaguda, Secunderabad-500 014, Telangana, India
* For Correspondence: E-mail: vijayasree_2002@yahoo.co.in


ABSTRACT

RP-HPLC method was developed and validated for the estimation of lurasidone hydrochloride as per ICH guidelines. A simple, fast, accurate and precise RP-HPLC method was developed by using acetonitrile: water containing 0.01% ortho phosphoric acid in the ratio of (50:50)v/v. The method was developed in Eclipse C18 column (100 mm × 4.6 mm, 3.5 μm particle size). The method was found to be linear in the range of 2.5- 15µg/ mL with a correlation coefficient value of 0.999. The accuracy studies of RP-HPLC method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range of 100.1-100.6% .The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.30-0.92.Satisfactory validation was also obtained from recovery (99.8%) studies, intra-day and inter-day precision and robustness 2%. The proposed method was found to be accurate, precise and rapid for the analysis of lurasidone.

Year 2019 | Volume No. 56 | Issue No.02 | Page No. 77-83
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