Development and Validation of a Zwitterionic Hydrophilic Interaction Liquid Chromatographic Method Coupled with PDA detection for the Quantitation of Risedronate in tablets.

Postgraduate Thesis uoadl:2862769 500 Read counter

Unit:
Κατεύθυνση Φαρμακευτική Ανάλυση-Έλεγχος Ποιότητας
Library of the School of Science
Deposit date:
2019-02-16
Year:
2019
Author:
Taxiarchi Eugenia
Supervisors info:
Ειρήνη Παντερή, Καθηγήτρια, τμήμα Φαρμακευτικής, Εθνικό και Καποδιστριακό Πανεπιστήμιο Αθηνών
Original Title:
Ανάπτυξη και επικύρωση μεθόδου υγροχρωματογραφίας υδρόφιλης αλληλεπίδρασης σε επαμφοτερίζουσα στήλη ZIC-pHILIC σε συνδυασμό με ανιχνευτή PDA για τον ποσοτικό προσδιορισμό της νατριούχου ρισεδρονάτης σε δισκία
Languages:
Greek
Translated title:
Development and Validation of a Zwitterionic Hydrophilic Interaction Liquid Chromatographic Method Coupled with PDA detection for the Quantitation of Risedronate in tablets.
Summary:
Risedronate sodium (1-hydroxy-2-(3-pyridinyl) ethylidene bisphosphonic acid monosodium salt), is a pyridinyl bisphosphonate that is used in the treatment of skeletal disorders as it modulates bone metabolism by the inhibition of osteoclast-mediated bone resorption. Risedronate along with other aromatic nitrogencontaining biphosphonates inhibits the activity the enzyme farnesyl pyrophosphate synthase (FPPS) which is involved in the mevalonate pathway. It reduces the risk of vertebral fracture and prevents nonvertebral osteoporosisrelated fractures in postmenopausal osteoporotic women and it is also effective in the treatment of Paget’s disease and other skeletal disorders. Biphosphonates are quite polar compounds, which by using reversed phase liquid chromatography are eluted very close to the solvent front.
In this work a hydrophilic interaction liquid chromatographic method coupled with diode array detection was developed and fully valitaded for the analysis of risedronate in pharmaceutical products. HILIC chromatography is a relatively new and promising technique for analysis and separation of polar substances which show little or minimal retention in the widely used reversed phase columns. As the elution order in HILIC is reversed to RP-HPLC a reasonable retention and selectivity for polar compounds is expected. Chromatographic conditions were optimized to achieve adequate retention of the parent drug and separation from tablets excipients. Various combinations of acetonitrile (organic modifier) and aqueous buffer solutions with changed content of each component were thoroughly investigated to identify the optimal mobile phase composition. The method was fully validated according to ICH guidelines. The proposed method is applicable as well for routine analysis and content uniformity test of risedronate in tablets and complies well with the validation requirements in the pharmaceutical industry.
Main subject category:
Science
Other subject categories:
Health Sciences
Keywords:
Risedronate, HILIC, PDA, quantitation, tablets
Index:
Yes
Number of index pages:
3
Contains images:
Yes
Number of references:
63
Number of pages:
106 σελίδες
File:
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master_Taxiarchi1.12.2018.pdf
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