A simple, rapid, and precise method is developed and validated on high performance liquid chromatography for the determination of impurities of Valsartan and Hydrochlorothiadizide in combined pharmaceutical dosage form. The chromatographic separation was performed on Inertsil ODS 3V, 5 µm (250 mm x 4.6 mm) using gradient elution of buffer-pH 2.5 (1 mL of triethylamine in 1000 mL of water. Adjust the pH to 2.5±0.05 with orthophosphoric acid) and Acetonitrile. The flow rate was maintained at 1.0 mL min-1 and UV detection was performed at 273 nm. The total run time was 40 min within which the main compound as well as all the known impurities and degradation impurities were separated. Stability indicating capability was established by forced degradation experiments and separation of known degradation products. The method was validated for accuracy, repeatability, reproducibility and robustness. Linearity, limit of detection and limit of quantitation was established for Valsartan as well as for Hydrochlorothiadizide and its known impurities.
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