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<p>A QbD stability-indicating RP-HPLC method for posaconazole and its related substances from API’s was developed and validated. Separation was accomplished by using Box–Behnken design by varying volume of acetonitrile, pH, and flow rate. Chromatographic separation was achieved on a Zorbax SB C18 column (4.6&#xa0;mm × 5.0&#xa0;μm) using an gradient program consists of mobile phase A phosphate buffer and mobile phase B acetonitrile and water in the ratio (80:20&#xa0;%v/v) at a flow rate of 0.8&#xa0;mL/min on a waters HPLC system. At 260&#xa0;nm, posaconazole was monitored and impurities were also detected. Acid/base hydrolysis, oxidation, photolysis, and thermal degradation, all performed stress testing that was shown to have major breakdown, per ICH guidelines. The method achieved a resolution greater than 2.0 between posaconazole and its degradants, with a correlation coefficient (r<sup>2</sup>) of 0.999 indicating excellent linearity. Its accuracy, precision, linearity, and robustness were all validated.</p>

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Quality by design-assisted stability-indicating RP-HPLC method development and validation of posaconazole and its related substances in active pharmaceutical ingredient

  • 期刊论文

  • 发表日期：

    2025年8月12日

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  • Anusha Gandi,
  • Vasudha Dadi,
  • Jagadeesh Adari,
  • Durga Ganesh Jami,
  • Mounica Peela

摘要

A QbD stability-indicating RP-HPLC method for posaconazole and its related substances from API’s was developed and validated. Separation was accomplished by using Box–Behnken design by varying volume of acetonitrile, pH, and flow rate. Chromatographic separation was achieved on a Zorbax SB C18 column (4.6 mm × 5.0 μm) using an gradient program consists of mobile phase A phosphate buffer and mobile phase B acetonitrile and water in the ratio (80:20 %v/v) at a flow rate of 0.8 mL/min on a waters HPLC system. At 260 nm, posaconazole was monitored and impurities were also detected. Acid/base hydrolysis, oxidation, photolysis, and thermal degradation, all performed stress testing that was shown to have major breakdown, per ICH guidelines. The method achieved a resolution greater than 2.0 between posaconazole and its degradants, with a correlation coefficient (r2) of 0.999 indicating excellent linearity. Its accuracy, precision, linearity, and robustness were all validated.