Paper Title
Development and validation of High Performance Liquid Chromatographic method for estimation of Lumateperone in formulation
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Registration ID: IJNRD_301522
Published ID: IJNRD2411006
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Keywords
Lumateperone, HPLC, Estimation, ICH, Validation
Abstract
A new RP-HPLC method was developed for the estimation of lumateperone in formulation as well as bulk and it was validated as per ICH guidelines. The chromatogram for was found to be satisfactory on symmetry C-18 (4.6×150mm, 5µ Hypersil column) using mobile phase composed of phosphoric acid buffer-Methanol (70:30, pH adjusted to 3.0 with orthophosphoric acid) at a flow rate of 0.8 ml/min and the detection wavelength of 245 nm. The retention time of lumateperone was found to be 2.698 min. The system suitability parameters proved that the proposed method is suitable for estimation of both the drugs under study. The theoretical plates for separation was found to be 5309 for lumateperone. The linearity for lumateperone was studied from 10 to 100 µg/ml concentrations and the calibration linear range was found to be 10 to 60 µg/ml. The precision of the method was good and the recovery of drugs was found to be within the acceptance limits of 80-120%. The LOD and LOQ for isoniazid were found to be 0.1277 µg/ml and 0.387 µg/ml respectively. The proposed RP HPLC method was found suitable for the estimation of lumateperone in dosage forms and is simple, selective, reproducible and accurate with good precision and can be successfully applied to routine analytical purpose.
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How To Cite (APA)
Piyush Gurav, Udit Narayan Soni, & Kavita R Loksh (November-2024). Development and validation of High Performance Liquid Chromatographic method for estimation of Lumateperone in formulation. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 9(11), a50-a59. https://ijnrd.org/papers/IJNRD2411006.pdf
Issue
Volume 9 Issue 11, November-2024
Pages : a50-a59
Other Publication Details
Paper Reg. ID: IJNRD_301522
Published Paper Id: IJNRD2411006
Research Area: Pharmacy All
Author Type: Indian Author
Country: Bhopal, Madhya Pradesh, India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2411006.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2411006
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