Development and Validation of Ultraviolet Spectroscopic Method for The Estimation of Tofacitinib Citrate

Abstract

Background: Tofacitinib Citrate (TFC) is a Janus kinase (JAK) inhibitor known for its immunomodulatory properties. Recent research has brought attention to the potential efficacy of utilizing this therapeutic modality for specifically targeting nanoparticles in a diverse range of medical conditions. Scholars have been diligently endeavoring to establish a dependable method of analysis for assessing the quality of these compounds. However, the currently accessible methodologies are deemed too expensive and time-intensive. In this research, we proposed the validated design of a rapid, accurate, cost-effective, and unobtrusive ultraviolet spectroscopic method for quantifying TFC in manufacturing nanoparticulate formulations.

Objective: The main objective of this study is to find an innovative UV visible spectroscopic methodology that is both easy and robust, while also demonstrating its accuracy and precision in determining the concentration of TFC in nano-formulations.

Methodologies: The highest absorption 288.60 was detected using a Shimadzu UV- 1800ENG240V,  double-beam UV visible spectrophotometer, which subsequently facilitated the creation of a UV spectrophotometric method. The characterization of Tofacitinib was conducted using the DSC and FTIR techniques.

Results: The results indicate that the validated UV Spectroscopic method was developed as per the guidelines mentioned by the International Conference of Harmonization (ICH). The use of the Beer-Lambert rule involved a stepwise dilution process ranging from 10 to 50 g/ml, resulting in a highly favorable correlation coefficient value of R2 = 0.999. The experiment has successfully proved the methods show a great linearity throughout the whole concentration range. The present methodology's percentage recovery was determined to be below the criterion for maintaining secrecy, specifically, less than 2% stated as the relative standard deviation (% RSD). Additionally, the methodology's accuracy was demonstrated for inter- and intraday variations, as indicated by the % RSD values. The Limits of detection (LOD) and Limits of quantification (LOQ) were determined to be 0.05048  µg/ml & 0.1529 µg/ml, respectively, using accurate calculations. During the specificity testing, no instances were observed for interfering peaks.

Conclusion: In conclusion, the quantification of tofacitinib within the polymeric nanoparticle formulation has been effectively accomplished utilizing the UV method presented in this study. This analytical approach holds the potential for assessing diverse pharmacological dosage forms.