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<p>Simultaneous high-performance thin-layer chromatography (HPTLC) method was developed and validated for the quantification of rivaroxaban and its aminomethyl process impurity/metabolite. Using a toluene–methanol–triethylamine (6:3.5:0.5%v/v/v) mobile phase, the method achieved optimized R<i>f</i> values of 0.75 for rivaroxaban and 0.38 for the impurity. The method exhibited a linear response for both analytes in the range of 800–1300&#xa0;ng/band, with correlation coefficients of 0.998 and 0.997, respectively. Sensitivity assessments revealed detection limits of 0.0086&#xa0;ng/band for rivaroxaban and 0.0165&#xa0;ng/band for the impurity, with quantification limits of 0.026&#xa0;ng/band and 0.050&#xa0;ng/band, respectively. Robustness and precision tests confirmed the method’s reliability, with %RSD values below 2.0 for all parameters. This validated HPTLC method offers an efficient solution for simultaneous determination of rivaroxaban and aminomethyl impurity/metabolite of rivaroxaban in pharmaceutical formulations. This simple HPTLC method provides a comprehensive approach for impurity profiling and quality control in pharmaceutical formulations. Its high sensitivity, reproducibility, and robustness make it a valuable tool in ensuring drug safety and compliance with regulatory standards.</p>

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HPTLC method for simultaneous determination of rivaroxaban and its aminomethyl process impurity/metabolite

  • 期刊论文

  • 发表日期：

    2025年7月3日

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  • Amit Shimpi,
  • Bhatu Patil,
  • Kunal Bhadane,
  • Yogesh Agrawal,
  • Vaishnavi Pawar,
  • Amod Patil,
  • Atul Shirkhedkar,
  • Iqrar Ahmad,
  • Harun Patel

摘要

Simultaneous high-performance thin-layer chromatography (HPTLC) method was developed and validated for the quantification of rivaroxaban and its aminomethyl process impurity/metabolite. Using a toluene–methanol–triethylamine (6:3.5:0.5%v/v/v) mobile phase, the method achieved optimized Rf values of 0.75 for rivaroxaban and 0.38 for the impurity. The method exhibited a linear response for both analytes in the range of 800–1300 ng/band, with correlation coefficients of 0.998 and 0.997, respectively. Sensitivity assessments revealed detection limits of 0.0086 ng/band for rivaroxaban and 0.0165 ng/band for the impurity, with quantification limits of 0.026 ng/band and 0.050 ng/band, respectively. Robustness and precision tests confirmed the method’s reliability, with %RSD values below 2.0 for all parameters. This validated HPTLC method offers an efficient solution for simultaneous determination of rivaroxaban and aminomethyl impurity/metabolite of rivaroxaban in pharmaceutical formulations. This simple HPTLC method provides a comprehensive approach for impurity profiling and quality control in pharmaceutical formulations. Its high sensitivity, reproducibility, and robustness make it a valuable tool in ensuring drug safety and compliance with regulatory standards.