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<p>Pyronaridine Tetraphosphate is a potent antimalarial agent used in combination therapies for treating Plasmodium falciparum and P. vivax infections. Accurate and reliable analytical methods are essential for its quality control and stability assessment.&#xa0;To develop and validate a robust, stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative estimation of Pyronaridine Tetraphosphate in bulk drug form.&#xa0;Chromatographic separation was achieved using a Kromasil C18 column (250&#xa0;mm × 4.6&#xa0;mm, 5&#xa0;μm) with a mobile phase of methanol and 0.1% orthophosphoric acid (20:80 v/v), at a flow rate of 1.0 mL/min. Detection was performed at 277&#xa0;nm. The method was validated according to ICH Q2(R1) guidelines for system suitability, linearity, accuracy, precision, specificity, robustness, and sensitivity. Forced degradation studies were conducted under acidic, alkaline, oxidative, thermal, and photolytic conditions.&#xa0;The method demonstrated a retention time of 3.73&#xa0;min, excellent linearity (R² = 0.9999) in the range of 80–120&#xa0;µg/mL, and acceptable recovery (98.0–102.0%). The limit of detection and quantification were 0.689&#xa0;µg/mL and 2.089&#xa0;µg/mL, respectively. Significant degradation was observed under alkaline conditions, confirming the method’s stability-indicating capability. The developed RP-HPLC method is accurate, precise, and stability-indicating. It is suitable for routine analysis and quality control of Pyronaridine Tetraphosphate in bulk drug form and complies with regulatory validation standards.</p>

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Stability Indicating Method Development and Method Validation for Estimation of Pyronaridine Tetraphosphate

  • 期刊论文

  • 发表日期：

    2026年1月16日

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  • Kavita Bhushan Vikhe,
  • Sandeep Suresh Sonawane

摘要

Pyronaridine Tetraphosphate is a potent antimalarial agent used in combination therapies for treating Plasmodium falciparum and P. vivax infections. Accurate and reliable analytical methods are essential for its quality control and stability assessment. To develop and validate a robust, stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative estimation of Pyronaridine Tetraphosphate in bulk drug form. Chromatographic separation was achieved using a Kromasil C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of methanol and 0.1% orthophosphoric acid (20:80 v/v), at a flow rate of 1.0 mL/min. Detection was performed at 277 nm. The method was validated according to ICH Q2(R1) guidelines for system suitability, linearity, accuracy, precision, specificity, robustness, and sensitivity. Forced degradation studies were conducted under acidic, alkaline, oxidative, thermal, and photolytic conditions. The method demonstrated a retention time of 3.73 min, excellent linearity (R² = 0.9999) in the range of 80–120 µg/mL, and acceptable recovery (98.0–102.0%). The limit of detection and quantification were 0.689 µg/mL and 2.089 µg/mL, respectively. Significant degradation was observed under alkaline conditions, confirming the method’s stability-indicating capability. The developed RP-HPLC method is accurate, precise, and stability-indicating. It is suitable for routine analysis and quality control of Pyronaridine Tetraphosphate in bulk drug form and complies with regulatory validation standards.