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A New Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) Method for Determination of Kinetin Riboside (Plant Hormone) in Dequalinium Chloride Based Self-assembled Vesicles: Development, Validation, and Force Degradation Study
The analytical procedure remains the fundamental part of formulation development in terms of quantification of the drug in the formulation. The purpose of the current study was to develop accurate, sensitive and rapid high performance liquid chromatography (RP-HPLC) method for the quantitation of ki...
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Published in: | Chromatographia 2023-04, Vol.86 (4), p.295-307 |
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Main Authors: | , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
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Summary: | The analytical procedure remains the fundamental part of formulation development in terms of quantification of the drug in the formulation. The purpose of the current study was to develop accurate, sensitive and rapid high performance liquid chromatography (RP-HPLC) method for the quantitation of kinetin riboside (KR) in KR-loaded dequalinium based vesicles, also known as DQAsomes. The chromatographic analysis was performed on C
18
column with detection wavelength of 269 nm for KR and 310 nm for dequalinium chloride (DQA). The mobile phase consisted of 0.01 M potassium phosphate buffer and methanol in gradient system. The method was further validated according to the guidelines set by ICH. The developed chromatographic method was found to be linear from 10 to 250 µg/mL with r
2
value of 0.9995. All other validation parameters including accuracy, precision, robustness, etc. were well within the acceptable limits. The current research also encompasses force degradation studies to understand the impact of different stressing conditions on the stability of drugs in the formulation. KR-loaded DQAsomes were formulated by modified film hydration method and characterized for particle size (215.32 ± 3.54 nm), size distribution (0.12 ± 0.004) and zeta potential (39.4 ± 3.04 mV). The developed and validated method was further applied to evaluate KR entrapment and loading from KR-loaded DQAsomes along with in vitro cumulative KR release from the formulation. This research would further act as a foundation for the quantification of the drug in other dequalinium-containing formulations.
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ISSN: | 0009-5893 1612-1112 |
DOI: | 10.1007/s10337-023-04246-3 |