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<p>A key aspect of pharmaceutical analysis that guarantees the efficacy, safety, and quality of medication items is impurity profiling. It involves the Identification and quantification of Impurities that may arise during synthesis. In this research, a Novel RP-HPLC method was developed and validated, including the separation of Impurities and quantification of Brompheniramine Maleate. The separation of all three main components and Impurities was achieved using Gradient mode with the use of a UV and PDA detector at 260&#xa0;nm wavelength. In port A of the mobile phase, 100% Potassium di-hydrogen phosphate buffer, pH 3.0, was kept, and in port B, 100% Acetonitrile was kept. Separation was achieved by using a Sunniest C18 column having dimensions 150 × 4.6&#xa0;mm, 3&#xa0;μm. 1.0&#xa0;ml/min flow rate was set with column temperature 30&#xa0;°C. Total run time was 40&#xa0;min showed separation of all three components i.e. Brompheniramine Maleate (BPM) retention time (RT) − 23.64, Dextromethorphan HBr (DMP) RT – 25.22, Phenylephrine HCl (PPN) RT – 3.66 and BPM’s impurities such as Chlorpheniramine related compound B (Impurity A) RT – 22.81, Chlorpheniramine (Impurity B) RT – 11.06, and Pheniramine (Impurity C) RT – 14.96 with resolution ≥ 2.0. A linear relationship (<i>r</i> = 0.99) was revealed for all known analytes with a concentration range of LOQ to 150%. The recovery study specifies the accuracy of the method obtained in a range of 95%-105%. The repeatability determined that the method is precise enough within the acceptance limit of 80%-120%. Excellent linearity, accuracy, specificity, precision, robustness, LOD, LOQ and system applicability results are shown by the proposed approach.</p>

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Development of an RP-HPLC–PDA method for brompheniramine impurity profiling in a multi-ingredient cough syrup

  • 期刊论文

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  • 发表日期：

    2026年1月3日

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  • Priyanka Raju Pataskar,
  • Gayatri Barabde,
  • Vijay Arjun Bagul,
  • Anand Radheshyam Tiwari

摘要

A key aspect of pharmaceutical analysis that guarantees the efficacy, safety, and quality of medication items is impurity profiling. It involves the Identification and quantification of Impurities that may arise during synthesis. In this research, a Novel RP-HPLC method was developed and validated, including the separation of Impurities and quantification of Brompheniramine Maleate. The separation of all three main components and Impurities was achieved using Gradient mode with the use of a UV and PDA detector at 260 nm wavelength. In port A of the mobile phase, 100% Potassium di-hydrogen phosphate buffer, pH 3.0, was kept, and in port B, 100% Acetonitrile was kept. Separation was achieved by using a Sunniest C18 column having dimensions 150 × 4.6 mm, 3 μm. 1.0 ml/min flow rate was set with column temperature 30 °C. Total run time was 40 min showed separation of all three components i.e. Brompheniramine Maleate (BPM) retention time (RT) − 23.64, Dextromethorphan HBr (DMP) RT – 25.22, Phenylephrine HCl (PPN) RT – 3.66 and BPM’s impurities such as Chlorpheniramine related compound B (Impurity A) RT – 22.81, Chlorpheniramine (Impurity B) RT – 11.06, and Pheniramine (Impurity C) RT – 14.96 with resolution ≥ 2.0. A linear relationship (r = 0.99) was revealed for all known analytes with a concentration range of LOQ to 150%. The recovery study specifies the accuracy of the method obtained in a range of 95%-105%. The repeatability determined that the method is precise enough within the acceptance limit of 80%-120%. Excellent linearity, accuracy, specificity, precision, robustness, LOD, LOQ and system applicability results are shown by the proposed approach.