Stability Indicating RP-HPLC Method For The Estimation Of Decitabine In Bulk Drug And Lipid Based Nanoparticles | 18750
Journal of Analytical & Bioanalytical Techniques
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The aim of our present work was to develop and validate a reverse phase high-performance liquid chromatography (RP-
HPLC) method for the determination of Decitabine (DCB). The developed method was further applied to observe the
degradation of DCB under various stress conditions. Chromatographic separation was achieved on C18, 250?4.6 mm, particle
size 5 μm, Agilent column, using ammonium acetate (0.01 M) as mobile phase with flow rate of 1 mL/min and injection volume
was 20 μL. Quantification was carried out with UV detector at 230 nm with a linear calibration curve in the concentration
range of 10-100 μg/mL based on peak area. Thus, developed method was validated for linearity, accuracy, precision, and
robustness. Linearity was found to be in the range between 10-100 μg/mL with a significantly higher value of correlation
=0.9994. The limits of detection (LOD) and the limits of quantification (LOQ) were found to be 1.92 μg/mL and
5.82 μg/mL respectively. Moreover, validated method was applied to study the degradation profile of DCB under various stress
degradation conditions. Examination of different stress conditions on degradation of DCB showed that its degradation was
highly susceptible to oxidative condition as 31.24% of drug was degraded. In acidic and alkaline conditions, the drug was
degraded by 21.03% and 12.16% respectively, while thermal and photolytic condition causes least degradation, i.e., 0.21%
and 0.3% respectively. Finally, the proposed method was found to be sensitive, specific and was successfully applied for the
estimation of DCB in bulk drug, and lipid based nanoparticles.
Kanchan Kohli completed her PhD from Hamdard University in 2001. She is currently working as an associate professor of the
Faculty of Pharmacy of Hamdard
University. Her research interests are Nanoparticulate drug delivery systems. She has more than 150 papers published in International Journals and authored more
than 10 chapters of books. She has filled 6 Indian patents and one US patent.
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