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International Journal of Science, Strategic Management and Technology

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DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF TOFACITINIB IN BULK FORM

AUTHORS:
N. B. Bhalke
Omkar Gotmukle
Dr. S. S. Patil
Dr. S. P. Kumbhar
Mentor
Dr. S. V. Garad
Affiliation
Department of Quality Assurance Maharashtra College of Pharmacy, Nilanga
CC BY 4.0 License:
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract

A simple, accurate, precise, and robust Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of Tofacitinib in bulk drug form. Chromatographic separation was achieved using a C18 column with a suitable mobile phase consisting of an aqueous buffer and organic solvent in optimized proportions. The analysis was carried out at an appropriate flow rate, and detection was performed using a UV detector at the selected wavelength. Tofacitinib exhibited a well-resolved peak with satisfactory retention time and peak symmetry. The developed method was validated according to International Council for Harmonisation (ICH) guidelines for various validation parameters including specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). The method demonstrated excellent linearity over the selected concentration range with a correlation coefficient close to unity. Recovery studies confirmed the accuracy of the method, while precision studies showed low relative standard deviation values, indicating good repeatability and intermediate precision. The robustness of the method was established by introducing small deliberate variations in chromatographic conditions without significantly affecting the results. The developed RP-HPLC method was found to be simple, reliable, cost-effective, and suitable for routine quality control analysis of Tofacitinib in bulk pharmaceutical materials.

Keywords
Tofacitinib RP-HPLC Method Development Method Validation Bulk Drug Analysis ICH Guidelines Quantitative Estimation Accuracy Precision Linearity Quality Control Pharmaceutical Analysis.
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Bhalke, N. B., Gotmukle, O., Patil, S. S. & Kumbhar, S. P. (2026). Development and Validation of RP-HPLC Method for Estimation of Tofacitinib in Bulk Form. International Journal of Science, Strategic Management and Technology, 02(6). https://doi.org/10.55041/ijsmt.v2i6.143

Bhalke, N., et al.. "Development and Validation of RP-HPLC Method for Estimation of Tofacitinib in Bulk Form." International Journal of Science, Strategic Management and Technology, vol. 02, no. 6, 2026, pp. . doi:https://doi.org/10.55041/ijsmt.v2i6.143.

Bhalke, N.,Omkar Gotmukle,S. Patil, and S. Kumbhar. "Development and Validation of RP-HPLC Method for Estimation of Tofacitinib in Bulk Form." International Journal of Science, Strategic Management and Technology 02, no. 6 (2026). https://doi.org/https://doi.org/10.55041/ijsmt.v2i6.143.

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  1. Modern Pharmaceutical analysis , Volume1-4, Satish Ahuja, CBS publishers and Dis-tributors, Newdelhi

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This article has undergone plagiarism screening and double-blind peer review. Editorial policies have been followed. Authors retain copyright under CC BY-NC 4.0 license. The research complies with ethical standards and institutional guidelines.
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