RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions.
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 C(18) 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 microg 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 microg mL(-1) and LOQ 0.1 microg 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% H(2)O(2). 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.
S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva-382711, Gujarat, India. riteshn.sharma@gmail.com
Ritesh N
RN
Sharma
Shyam S
SS
Pancholi
D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D007093:Imidazoles / Q000032:analysis* / Q000737:chemistry*; D000068557:Olmesartan Medoxomil; D015203:Reproducibility of Results; D013607:Tablets; D013777:Tetrazoles / Q000032:analysis* / Q000737:chemistry*
D007093:Imidazoles; D013607:Tablets; D013777:Tetrazoles; D000068557:Olmesartan Medoxomil