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Forced degradation study with a developed and validated RP-HPLC method for determination of cefpodoxime proxetil in the bulk and finished pharmaceutical products

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The present study aimed to develop an HPLC method of Cfp analysis which enjoyed highly linearity, repeatability, robustness, ruggedness, selectivity, rapidly, and economic to use. The chromatographic method uses a… Click to show full abstract

The present study aimed to develop an HPLC method of Cfp analysis which enjoyed highly linearity, repeatability, robustness, ruggedness, selectivity, rapidly, and economic to use. The chromatographic method uses a column Inertsil ODS-3 (250 mm × 4.6 mm × 5 µm). The mobile phase consists of a mixture of acetonitrile: acetate buffer (4:6, v/v) at isocratic flow rate 1.5 mL/min with PDA detector at 240 nm, column oven adjusted at 30 °C, and injection volume 20 µL. The method revealed that satisfied linearity regression R2 (0.9998) with repeatability (0.77%) with LOD and LOQ: 1.102 µg/mL and 3.340 µg/mL respectively. The method showed a successful application of analytical method validation for Cfp in bulk and pharmaceutical formulations.

Keywords: forced degradation; bulk; method; degradation study; hplc method

Journal Title: Journal of the Iranian Chemical Society
Year Published: 2019

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