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Development and validation of clopidogrel bisulphate determination in bulk by UV spectrophotometric method

Lyudmyla Antypenko, Svitlana Gladysheva, Svitlana Vasyuk

Abstract

A simple, rapid, sensitive and low cost UV-spectrophotometric method has been developed for the quantification of clopidogrel bisulphate in pure substance. It was validated for linearity, range, accuracy, precision, ruggedness and robustness. The valid maximum absorbance was recorded at the 203 nm wavelength in the concentration ranges 1.0-2.6 mg/100mL of clopidogrel bisulphate in methanol solution after 15 min stirring. The limit of detection was found to be 0.59 mg/100mL, while limit of quantification was 1.78 mg/100mL. The calibration curve was linear with r2 = 0.9929. The proposed technique could be successfully used for the determination of clopidogrel bisulphate in bulk in small laboratories without LC−MS spectrometer or HPLC-UV chromatograph, as well as for future pharmacokinetic studies in pharmaceutical dosage forms.


Keywords

clopidogrel bisulphate; validation; UV-spectrophotometry

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DOI: http://dx.doi.org/10.14748/ssp.v3i2.1704

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About The Authors

Lyudmyla Antypenko
Zaporizhzhya State Medical University
Ukraine

Assistant Professor

Organic and Bioorganic Chemistry Department

Svitlana Gladysheva
Zaporizhzhya State Medical University
Ukraine

Technology of Drugs Department

Svitlana Vasyuk
Zaporizhzhya State Medical University
Ukraine

Analytical Chemistry Department

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