TY - JOUR AU - TABASSUM, RAHEEN AU - RIZWAN, S. H. PY - 2023/02/01 Y2 - 2024/03/29 TI - STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF RUXOLITINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM USING UPLC JF - International Journal of Pharmacy and Pharmaceutical Sciences JA - Int J Pharm Pharm Sci VL - 15 IS - 2 SE - Original Article(s) DO - 10.22159/ijpps.2023v15i2.46839 UR - https://journals.innovareacademics.in/index.php/ijpps/article/view/46839 SP - 40-46 AB - <p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">Objective: </span></strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">To establish a simple and selective UPLC (Ultra-high Performance Liquid Chromatography) method for the determination of Ruxolitinib in tablet and bulk dosage forms. </span></p><p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">Methods</span></strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">: Chromatographic separation was achieved on a C8 column with the dimensions of (250×4.6m ID) 5 µm length; the mobile phase composition was a mixture of pH 6.2 with glacial acetic acid: Methanol: acetonitrile in the ratio of 40:30:30 was passed through the designated column with a flow rate of 1 ml per minute and the UV <span style="background: white;">(Ultra Violet)</span> detection was witnessed at 254 nm. </span></p><p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">Results: </span></strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">Linearity was observed in the range 50-150 µg/ml for Ruxolitinib (r² =0.9998) for drugs estimated by the proposed methods was in good agreement with the label claim. The % recovery of the drug was found to be between 98 and 102%. The drug was used for determining stability studies for acid, alkali, thermal, photolytic, and peroxide degradation.</span></p><p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">Conclusion: </span></strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">The method for determining Ruxolitinib was discovered to be simple, precise, accurate, and high resolution, with a shorter retention time, making it more acceptable and cost-effective for routine analysis.</span></p> ER -