METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TOFACITINIB IN TABLET DOSAGE FORM BY USING RP-UHPLC
Method Development, Validation, Tofacitinib, Tablet Dosage, RP-UHPLC
The new analytical method for the UHPLC method was established for Tofacitinib then optimized and then applied on pharmaceutical dosage forms. Various mobile phase systems were prepared and used to provide an appropriate chromatographic separation, but the proposed mobile phase comprising of Buffer, Acetonitrile and methanol in the ratio 40:40:20 gave a better resolution and sensitivity. The detection was carried out by using UV detector at 290nm using Thermo scientific (4.6mmX 3mm,5µm). Among these several flow rates tested, the flow rate of 0.7ml was found to be the best for Tofacitinib with respect to retention times and theoretical plates. The retention time is 2.129 for Tofacitinib. The asymmetry factor or the tailing factor was found to be 1.4 for tofacitinib, which indicates symmetrical nature of the peak. System suitability parameters such as retention time, tailing factor, capacity factor and number of theoretical plates were calculated. The number of theoretical plates was found to be around 2210 for Tofacitinib, which indicates efficient performance of the column.These parameters represent the specificity of the method. Linearity range was evaluated by the visual inspection of plot of peak area as a function of analyte concentration and the corresponding calibration graphs were shown in figure and results are shown in table. From the linearity studies, the specified concentration range was determined. It was observed that Tofacitinib was linear in the range of 50% to 150% for the target concentrations. The validation of the proposed method was verified by system precision and method precision. The %RSD for system precision and method precision of Tofacitinib was tabulated. Placebo interference studies were made by injecting placebo alone, then the standard and the placebo along with the standard. They did not show any interference of placebo at the RT of the analyte peak. Robustness studies were made by varying the flow rate and also by performing filter validation studies on to types of filters. The analytical data and results for filter validation were tabulated, hence the developed method was found to be robust. Study of ruggedness was made by conducting the study on different system and by two analysts. The results were found to be in limits and were tabulated and hence the developed method is found to be rugged.
"METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TOFACITINIB IN TABLET DOSAGE FORM BY USING RP-UHPLC", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.9, Issue 6, page no.1000 - 1007, June-2024, Available :https://ijsdr.org/papers/IJSDR2406116.pdf
Volume 9
Issue 6,
June-2024
Pages : 1000 - 1007
Paper Reg. ID: IJSDR_211812
Published Paper Id: IJSDR2406116
Downloads: 000347095
Research Area: Pharmacy
Country: Kurnool, Andhra pradesh, India
ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
Publisher: IJSDR(IJ Publication) Janvi Wave
