TITLE

STABILITY-INDICATING HPLC DETERMINATION OF CIPROFIBRATE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

AUTHOR(S)
Jain, P. S.; Jivani, H. N.; Khatal, R. N.; Surana, S. J.
PUB. DATE
January 2012
SOURCE
Chemical Industry & Chemical Engineering Quarterly;2012, Vol. 18 Issue 1, p95
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
A novel stability-indicating high-performance liquid chromatographic assay method was developed and validated for quantitative determination of ciprofibrate in bulk drugs and in pharmaceutical dosage form in the presence of degradation products. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using an Ace5-C18 (250 mmx4.6 mm, 5 µm) advanced chromatography column, and methanol and water (90:10 v/v) as a mobile phase. The detection was carried out at a wavelength of 232 nm. The ciprofibrate was subjected to stress conditions of hydrolysis (acid and base), oxidation, photolysis and thermal degradation. Degradation was observed for ciprofibrate in base, in acid and in 30% H2O2. The drug was found to be stable in the other stress conditions attempted. The degradation products were well resolved from the main peak. The percentage recovery of ciprofibrate was from (98.65 to 100.01%) in the pharmaceutical dosage form. The developed method was validated with respect to linearity, accuracy (recovery), precision, system suitability, specificity and robustness. The forced degradation studies prove the stability indicating power of the method.
ACCESSION #
74425735

Tags: DRUG stability;  HIGH performance liquid chromatography;  DRUGS -- Dosage forms;  CHROMATOGRAPHIC analysis;  HYDROLYSIS;  PHOTOLYSIS (Chemistry)

 

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