Aim: Upadacitinib is a Janus kinase/signal transducers and activators of transcription (JAKs) of cytoplasmic tyrosine kinase that has been proven to be effective in treating inflammatory conditions and various immunological diseases/disorders, including rheumatoid arthritis. Tofacitinib and ruxolitinib, which are members of this drug's first generation, did not affect JAK1/JAK3 or JAK1/JAK2 receptors specifically due to a lack of subtype selectivity. As far as we are aware, there is currently no method for the accurate quantification of the anti-rheumatic drug upadacitinib in biological fluid.Material and Materials: To detect upadacitinib in biological fluid, an unique and reliable LC-MS/MS technique must be developed. Using a symmetric C18 column (150 x 4.6 mm, 3.5 m) and isocratic elution with acetonitrile: water (50:50) as the mobile phase, we created a unique bioanalytical approach here. Formic acid was used to bring the mobile phase's pH down to 4.0, and the flow rate was 1 ml/min. The retention time of the medication was discovered to be 3.12 min, and the total run time was set to 7 min.Results: With a correlation coefficient (r2) of 0.999, the upadacitinib linearity curve was established at concentrations ranging from 12.5 ng/ml to 100 ng/ml. The theoretical plates, resolution, and tailing factor are system suitability parameters found to be within the acceptable criteria. The recovery studies indicated that the developed method can extract the acceptable % amount of drug 100.3%. The matrix effect study indicates there is no effect of matrix on recovery, the result shown as 104.20% and also other validation parameters like precision, LOD, LOQ are within the acceptable criteria.Conclusion: The created techniques enable a precise, delicate, and consistent analytical process for the estimation of Upadacitinib in biological matrix. The stability studies indicate the drug is stable in different accelerated stability study conditions the results are within limits.
Cancer medication Glasdegib, created by Pfizer, has FDA approval. It serves as a tiny molecule an inhibitor of sonic hedgehog, a protein that is overexpressed in several cancer types. Like the majority of medications in its class, it inhibits the smoothened form that contains the hedgehog's sonic receptor (SMO). Clinical trials in phase II are ongoing in four instances. One is testing glasdegib's ability to treat myelofibrosis in patients whose condition was resistant to ruxolitinib treatment. We're aware of no method for precisely measuring Glasdegib, an anti-cancer medication, in biological fluids at the moment. A novel, simple& robust LC-MS/MS method was developed in to detect Glasdegib in a biological fluid. Here, we came up with a novel bioanalytical method using isocratic elution with a symmetric C18 column (150 x 4.6 mm, 3.5 µm), acn: 0.1% formic acid (30:70) was used as mobile phase pH of the mobile phase was adjusted to 4.0 using 0.1% formic acid at rate of flow for 1 ml/min. The drug retention was found as 2.622 minutes, and the total analysis time was set for 6 minutes. The Glasdegib calibration curve was drawn at concentrations ranging from 6 ng to 120 ng/ml of Glasdegib, with regression coefficient (r2) of 0.999. System suitability parameters for resolution, tailing factor and theoretical plates, are found in acceptable limits. The recovery studies indicated that 99.94% of the drug can be extracted using the developed method in an acceptable ratio. The results of the matrix effect study show that the matrix has no impact on recovery; the result is 98.55%, and some other validation parameters are accuracy, linearity, robustness, LOD and LOQ are found in acceptable limits. The developed method should follow an analytical approach like precise, sensitive, and accurate for the evaluation of Glasdegib in biological matrix. The results of the accelerated stability studies reveal that the drug is stable under various conditions, according to USFDA Guidelines.
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