Develops and validates UV and RP-HPLC methods for Rivaroxaban, indicating reliable pharmaceutical analysis.
Abstract:This study aimed to develop and validate UV spectrophotometric and Quality by Design (QbD)-assisted RP-HPLC methods for the quantitative estimation of Rivaroxaban. UV spectrophotometricanalysis was performed using Methanol:Water (50:50 v/v) as diluent, and the maximum absorbancewas observed at 249 nm. The UV method exhibited excellent linearity over the concentration rangeof 4–20 μg/mL with a correlation coefficient (R2) of 0.9994. The RP-HPLC method was optimizedusing a Box–Behnken Design (BBD) under QbD principles. Chromatographic separation wasachieved on a C18 column using Buffer:Acetonitrile (60:40 v/v) as the mobile phase. The developedmethods were validated according to ICH Q2(R1) guidelines and demonstrated satisfactory linearity,accuracy, precision, sensitivity, and robustness. The optimized methods were found to be reliable,reproducible, and suitable for routine quantitative analysis of Rivaroxaban in pharmaceutical dosageforms.
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Ms. Bhavana Bhujangrao Kakad, Mr. Yogiraj Prakashrao Muley, Dr. Sunil Shivhari Jaybhaye, Ms. Archana Shivaji Jamdhade, Mr. Sanket Anil Ingle (2026) studied this question.
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