A1 Vertaisarvioitu alkuperäisartikkeli tieteellisessä lehdessä
Stability-Indicating Assay Method for Estimation of Olmesartan Medoxomil and its Metabolite
Tekijät: Trivedi P, Kartikeyan C, Kachave R, Bhadane R
Kustantaja: TAYLOR & FRANCIS INC
Julkaisuvuosi: 2009
Lehti: Journal of Liquid Chromatography and Related Technologies
Tietokannassa oleva lehden nimi: JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
Lehden akronyymi: J LIQ CHROMATOGR R T
Artikkelin numero: PII 910537573
Vuosikerta: 32
Aloitussivu: 1516
Lopetussivu: 1526
Sivujen määrä: 11
ISSN: 1082-6076
DOI: https://doi.org/10.1080/10826070902901606
Tiivistelmä
A novel stability indicating high performance liquid chromatographic assay method was developed and validated for Olmesartan medoxomil and its degradant product. An isocratic HPLC method was developed to separate the drug from the degradation products, using an Inertsil-ODS-3 (C-18) Column (5m, 250mm4.60mm). A mixture of phosphate buffer (pH 4.0) and methanol (30:70) was used as mobile phase. The flow rate was 1.0mL/min and the detection was carried out at 230nm. The validation studies were carried out fulfilling the International Conference on Harmonisation (ICH) requirements. The procedure was found to be specific, linear, precise (including intra and inter day precision), accurate, and robust.
A novel stability indicating high performance liquid chromatographic assay method was developed and validated for Olmesartan medoxomil and its degradant product. An isocratic HPLC method was developed to separate the drug from the degradation products, using an Inertsil-ODS-3 (C-18) Column (5m, 250mm4.60mm). A mixture of phosphate buffer (pH 4.0) and methanol (30:70) was used as mobile phase. The flow rate was 1.0mL/min and the detection was carried out at 230nm. The validation studies were carried out fulfilling the International Conference on Harmonisation (ICH) requirements. The procedure was found to be specific, linear, precise (including intra and inter day precision), accurate, and robust.
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