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A. S. K. Sankar ¹, P. Shanmugasundaram ¹, B. Datchayani ¹, N. Balakumaran ¹, Mohammed Rilwan ¹, R. Subaranjani ¹, M. Sumithra ¹

Affiliations
1 Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels University (VISTAS) , Chennai-600117, IN

Abstract

Aim: The aim is to develop simple validated analytical method for analysis of Tofacitinib by UV Spectroscopy and to study the forced degradation and stress conditions have been used to detect the stability of Tofacitinib. Method: Tofacitinib was estimated at 285.9nm. Linearity range was found to be 10-50 mcg/ml. The correlation coefficient was found to be 0.9996. The molar absorptivity was found to be 12468.77mol/cm. The proposed method Sandell's sensitivity was found to be 0.040410 μg cm²/0.001AU. The limit of detection and quantification were found to be 0.8169 and 2.4755 μg/ ml respectively. The degradation behavior of Tofacitinib was carried out as per the standard procedures and guidelines. Forced acid hydrolytic degradation, alkali degradation and oxidative degradation of was performed in bulk Tofacitinib and laboratory prepared admixtures using 1M Hydrochloric acid up to 48 hrs, in 10 % Hydrogen peroxide up to 48 hrs and for 1.0 M Sodium hydroxide up to 10 min at room temperature. The resulting solutions were analyzed for content by UV spectrophotometry at the maximum absorption of 285.9 n. The assay value of Tofacitinib in bulk and physical admixture was calculated at different time intervals for intraday and interday experiments. Results and Conclusions: The proposed method was successfully applied for the determination of tofacitinib in pure and laboratory prepared physical mixtures. The % RSD value of Tofacitinib in bulk and physical admixture was calculated at different time intervals for recovery , precision (Iintraday and Interday experiments) and quantification studies were found to be less than 2 %.

Keywords

Tofacitinib, UV-Spectroscopy, Validation, ICH Guidelines, Isocratic.

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A. S. K. Sankar ¹, B. Datchayani ¹, N. Balakumaran ¹, Mohammed Rilwan ¹, R. Subaranjani ¹

Affiliations
1 Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels University (VISTAS), Chennai-600117, IN

Abstract

Aim: The aim is to develop simple validated analytical method for analysis of Tofacitinib by RP HPLC in pure and laboratory prepared physical admixtures. Method: Tofacitinib was estimated by RP HPLC using methanol , water mixture as mobile phase. Linearity range was found to be 10-50 mcg/ml. The correlation coefficient was 0.9998. The limit of detection and quantification were found to be 0.053 and 1.63 μg /ml respectively. The drug solutions were scanned in UV spectrophotometry and the maximum absorption was found to be 285.9 nm and the same was fixed as detecting lambda by RP HPLC method. The Column used was C₁₈.with the dimensions of 150 mm X 4.6 mm and 5 micron particles. Results and Conclusions: The proposed method was successfully applied for the determination of tofacitinib in pure and laboratory prepared physical mixtures. The % RSD value of Tofacitinib in bulk and physical admixture was calculated at different time intervals for recovery , precision (Iintraday and Interday experiments) and quantification studies were found to be less than 2 %.

Keywords

Tofacitinib, RP HPLC, Validation, ICH Guidelines, Isocratic.

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