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Evaluation of impurities in simvastatin drug products with the use of FT-IR spectroscopy and selected chemometric techniques

100%
Kupcewicz B., Ronowicz J., Balcerowska-Czerniak G., Walasek A., Budzisz E.
Open Chemistry
|
2013
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vol. 11
|
issue 8
1320-1329
EN
In the present study a reversed phase high performance liquid chromatography (RP-HPLC) method with diode array detector (DAD) at room temperature was used for obtaining impurity profiles of 20 drug products containing simvastatin as an active substance. Fourier-transform infrared spectroscopy (FT-IR) was carried out to obtain absorption spectra of samples. The partial least squares (PLS) model was built to predict the relative content of lovastatin, the main impurity of simvastatin, and sum of statin-like impurities. In order to build the PLS model, peak areas obtained from HPLC chromatograms were related to FT-IR spectra of drugs. The PLS model based on signal normal variate and orthogonal signal correction (SNV+OSC) transformed FT-IR spectra was able to predict the content of drug impurities in real samples with a good prediction ability (R2 > 0.95). [...]
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Development and validation of an ultra-fast liquid chromatographic method for the quality control of famotidine formulations using a short monolithic stationary phase

88%
Tzanavaras P.
Open Chemistry
|
2011
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vol. 9
|
issue 3
446-452
EN
An HPLC method for the quality control of famotidine (FMT) containing formulations has been developed and validated. The combination of a short monolithic column (Chromolith® RP-18e 50 × 4.6 mm i.d.) and an elevated flow rate (3.0 mL min−1) enabled the proposal of a high-throughput analytical scheme capable of reliable operation in a demanding industrial environment. Detection was carried out at 265 nm. Thorough validation of the method included linearity (5–150%), limits of detection (0.13%) and quantification (0.41%), selectivity, precision (within- and day-to-day), accuracy and ruggedness. The new method was applied successfully to the analysis of samples (assay, dissolution, dosage & blending uniformity) during the production of four validation batches of FMT-containing tablets.
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