“Development and Validation of Uv Spectroph...

“Development and Validation of Uv Spectrophotometric and Rp- Hplc Method for Estimation of Lumateperone In Solid Dosage Form”

Author Name : Dhami Foram R., Miss. Komal dhudashia

ABSTRACT

Lumateperone was eluted RPHPLC and UV spectroscopy Colum Inertsil ODS Column (150x4.6 mm,5µ) at Detector wave length 245 nm  Mobile phase 0.02%V/v/v Formic acid:Methanol(70:30v/v)and the peak purity value greater than 0.9999 for Lumateperone this showed that the method wasspecific. Linearity studies were performed at 10-50μg/mL of Standard drug solution % RSD of peak areas were determined. Correlation coefficient was calculated, the data found within the acceptance criteria of 0.99.The result was found to be within limit so the method is linear over the concentration range of 10-50μg/mL of Lumateperone.% RSD of area response of Lumateperone was 0.152 for system precision and 0.317 for methodprecision % RSD of retention times of Lumateperone was 0.055 for system precision and 0.061 for method precision 80%, 100%, 120% to the drug product solution comprising of 30µg/mL. The % RSD and the % Recovery were within the acceptable limits of 98-102 in all cases. The recovery of Lumateperone was found to be 99.52-100.66%, which indicates a good accuracy of the method to that of the labelclaim. LOD for Lumateperone was found to be 0.6065g/mL, indicating high sensitivity of themethod LOQ for Lumateperone was found to be 1.838µg/mL, indicating high sensitivity of themethod. % RSD for the parameters like tailing factor of Lumateperone was found to be 1.20, retention time of Lumateperone was found to be 1.25 and the theoretical plates of Lumateperone was found to be 0.449 The % RSD of tailing factor, retention time and theoretical plates of Lumateperone was found to be less than2. % variation of Lumateperone was found to be 0.293%. It was found out that the solution remained stable for 24 hours when stored at 8°C.The percentage assay for Lumateperone was found to be99.43% Assay was performed by the data was found suitable and within the acceptance range of 100 ± 2%..

Keyword: RPHPLC,Lumateperone, UV, Inertsil ODS Column