1Taywade College of Pharmacy, Koradi, Nagpur, Maharashtra, India
2RMD Institute of Pharmaceutical Education & Research, Pune, Maharashtra, India
3PES’s Modern College of Pharmacy, Sector No. 21, Yamuna Nagar, Nigdi, Pune, Maharashtra, India
*Corresponding Author E-mail: minalresearch@gmail.com
Online Published on 25 January, 2024.
This paper describes the development of HPTLC method for the quantitative determination of Ruxolitinib in bulk and tablet dosage form using a systemic approach. A. simple, precise, accurate and specific high performance thin layer chromatographic method has been developed and validated for the Ruxolitinib in bulk and marketed formulation.
The solvent system was 8.0:2.0:0.05 v/v/v of chloroform, methanol, and formic acid. This system was found to give compact spots for Ruxolitinib (Rf value of (0.71±0.02) Densitometric analysis of Ruxolitinib was tested in the absorbance mode at 236nm.
The developed method produced linear results with R2 = 0.998 for a range of 100 - 600ng/band. The accuracy of the method was determined at 80, 100, and 120% level. The % recoveries were found to be 100.01%, 99.13%, and 99.82% which are within the limit of 99% to 101%. The LOD and LOQ were found to be 8.19 ng/band and 25.06ng/band indicating the sensitivity of the method. Using the developed method, it was found that intraday and interday RSD values were less than 2%. The method was also found to be robust as indicated by the % RSD values less than 2%.
The present method was validated according to the ICH guidelines and it is applied successfully for the determination of Ruxolitinib in tablets.
Ruxolitinib, HPTLC, Validation, Method development, ICH Guidelines
