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Method Development and Validation of Degradation Studies of Palbociclib by RP-HPLC
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| Author:
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, PUNNA VENKATESHWARLU, MEHUL M.PATEL
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| Abstract:
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Background: A simple, economical, authentic, and faithful method was used for the study of palbociclib. The Chromatographic analysis was performed by using a C18 intersil ODS (250 X 4.6 mm, 5µm) and a mobile phase containing 0.5M Ammonium acetate: Acetonitrile (40:60) v/v was passed throughout the column maintained at a temperature of 25 °C with a flow rate of 1 ml/min. Approximately, 10 µL of drug solution was injected and the analytes were eluted at 266 nm.
Results: The Retention time of palbociclib was 4.813 minutes. The system suitability percentage RSD of palbociclib is 0.11%. The Assay of palbociclib was found to be 98.85%. LOD, LOQ values of palbociclib
were found to be 4.87 & 14.77 µg/ml, respectively. Regression equation of palbociclib was found to be
y= 71068x + 33776. Palbociclib was found to be get degraded in peroxide stress conditions, while no degradation was observed in acid, base, photolytic and thermal conditions. All verification parameters are within the range according to the ICH guidelines, and the degradation products are also within the limits, which shown that the method is stable.
Conclusion: The HPLC method development and validation data shown that this is a reliable method which can be used for analyzing regular quality control. The proposed HPLC method was found to be specificity, linearity, precision, intermediate precision, and accuracy. In the currently developed RP-HPLC analytical method, the run time is reduced, which proves that the method is economical and widely acceptable, also simple and practical, which can be used in routine quality control tests in the industry.
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| Keyword:
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Palbociclib, Validation, Retention time, Degradation studies, RSD
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.166
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| Download:
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