Rapid RP-HPLC method development and validation of lurasidone hydrochloride in bulk and tablet form
By: Vijaya Sri K
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Contributor(s): Shiva Kumar M.
Publisher: Mumbai Indian Drug Manufacture's Association - IDMA 2019Edition: Vol.56(2), Feb.Description: 77-83p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian drugsSummary: 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.
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Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2020666 |
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.
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