Unit:
Κατεύθυνση Έλεγχος Φαρμακευτικών Ενώσεων (Φαρμακευτική Ανάλυση)Library of the School of Science
Author:
Τσαπάρα Ελισσάβετ-Σαββούλα
Supervisors info:
Μιχαήλ Κουππάρης Καθηγητής
Original Title:
Ανάπτυξη και επικύρωση μεθόδων υγροχρωματογραφίας υψηλής απόδοσης (HPLC) για τον ποσοτικό προσδιορισμό της πρεγκαμπαλίνης και των συγγενών της ουσιών σε κάψουλες και τη διαλυτοποίηση καψουλών
Translated title:
Development and Validation of HPLC methods for the assay, impurities and dissolution determination of Pregabalin, in capsules.
Summary:
In this project, analytical methods for the detection and quantification of
Pregabalin, its impurities and its dissolution of the capsules of this, were
developed / validated and validated, with high performance liquid
chromatography (HPLC) technique.
For these methods the same stationary phase, Inertsil ODS 3, diameter 250x4,6
mm, 5 μm was used and the same buffers of KH2PO4 in combination with amounts of
Acetonitrile were also used. In all methods, the two mobile phases followed a
gradient elution program. The flow rate of the mobile phase was set at 1.0 ml /
min for the determination of impurities and at 0.9 ml / min for the assay and
dissolution test of Pregabalin capsules, while the column temperature was set
at 30 °C. The samples remained in the auto sampler at 5 °C, while the volume of
the loop was adjusted to 100 μl for the impurities and dissolution method and
at 50 μl for the assay method. The detector used was a UV-visible detector set
at 210 nm.
Τhe analytical methods were evaluated for linearity, accuracy, precision and
stability, while the limits of detection and quantification of impurities were
determined using the method of signal to noise ratio. System suitability was
performed every day.
All methods were found reliable, with good linearity, repeatable and accurate,
therefore they considered as suitable for the determination of the assay,
impurities and dissolution test of Pregabalin.
Keywords:
Pregabalin, HPLC, Assay method, Impurities method, Dissolution method
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