Acta Pharmaceutica, Vol. 60 No. 1, 2010.
Izvorni znanstveni članak
https://doi.org/10.2478/v10007-010-0010-2
RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions
RITESH N. SHARMA
; S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva-382711, Gujarat, India
SHYAM S. PANCHOLI
; S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva-382711, Gujarat, India
Sažetak
A simple, sensitive and precise RP-HPLC-DAD method was developed and validated for the determination of olmesartan medoxomil (AT-II receptor blocker) in the presence of its degradation products. Olmesartan medoxomil and all the degradation products were resolved on a C18 column with the mobile phase composed of methanol, acetonitrile and water (60:15:25, V/V/V, pH 3.5 by orthophosphoric acid) at 260 nm using a photodiode array detector. The method was linear over the concentration range of 1–18 µg mL 1 and precise with RSD < 1% in intra- and inter-day study. Excellent recoveries of 99.3 ± 0.9 to 100.8 ± 1.2 % proved the accuracy of the method. Developed method was specific, as indicated by chromatographic resolution > 2.0 for each peak and sensitive with LOD 0.03 µg mL−1 and LOQ 0.1 µg mL−1. The method was used to study the drug degradation behavior under forced conditions. Four degradation products (DP-I, II, III, IV) were formed during the degradation study in 0.1 mol L−1 HCl whereas only DP-I, II and III were formed in water, 0.01 mol L−1 NaOH and 3 % H2O2. No significant thermal or photolytic degradation was observed in solid drug. The method was applied successfully for the assay of olmesartan medoxomil in the tablet dosage form.
Ključne riječi
olmesartan medoxomil; forced degradation; high performance liquid chromatography; stability
Hrčak ID:
48284
URI
Datum izdavanja:
1.3.2010.
Posjeta: 4.041 *