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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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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.

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Abbreviations

Cfp:

Cefpodoxime proxetil

Cfp S:

Cefpodoxime S isomer

Cfp R:

Cefpodoxime R isomer

HPLC:

High-performance liquid chromatography.

PDA:

Photodiode array detector

UV:

Ultraviolet

FT-IR:

Fourier-transform infrared spectroscopy

EP:

European Pharmacopeia

USP:

United States Pharmacopeia

LOD:

Limit of detection

LOQ:

Limit of quantitation

Conc:

Concentration

P. A:

Peak area

STDEV:

Standard deviation

RSD:

Relative standard deviation

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Acknowledgements

The author presents great thanks to Smart Pharma Company for supporting this work.

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Authors and Affiliations

  1. Chemistry Department, Faculty of Science, New Valley University, Al-Kharja, 72511, Egypt

    Mostafa F. Al-Hakkani

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  1. Mostafa F. Al-Hakkani
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Correspondence to Mostafa F. Al-Hakkani.

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Al-Hakkani, M.F. Forced degradation study with a developed and validated RP-HPLC method for determination of cefpodoxime proxetil in the bulk and finished pharmaceutical products. J IRAN CHEM SOC 16, 1571–1578 (2019). https://doi.org/10.1007/s13738-019-01630-5

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