Acid- Alkali Degradation Study on Olmesartan Medoxomil and Development of Validated Stability-Indicating Chromatographic Methods

Abstract

A reversed phase liquid chromatography (RP-HPLC) and thin layer chromatography (HPTLC) densitometry methods as a stability indicating assays of olmesartan medoxomil in presence of its acid or alkaline induced degradation products were developed. Olmesartan medoxomil and its degradation products were analyzed by HPLC equipped with UV-Variable wave length detector at 257 nm where quantitation was achieved by isocratic elution on Agilent, Exclipse XDB-C 18 column with mobile phase composed of acetonitrile: methanol: water: glacial acetic acid (40:35:25:0.1 v/v/v/v) at flow rate 1ml min.-1 . HPTLC was performed on aluminum packed Nano silica gel 60 F 254 TLC plates as stationary phase with significant difference in Rƒ values between olmesartan medoxomil and its degradates using chloroform: methanol: formic acid (8:1.5:0.5 v/v/v) as mobile phase. Densitometric evaluation of intact drug was carried out at 260 nm. The calibration curve of olmesartan medoxomil in bulk form was linear from 0.5-10 µg ml -1 and 0.05-1 mg ml -1 with mean percentage accuracy 99.97 ± 1.085 % and 100.35 ± 1.060 % for HPLC and HPTLC methods, respectively. The two proposed methods were successfully applied for the determination of olmesartan medoxomil in drug substance and in drug product. Methods validation was tested for linearity; accuracy; precision; selectivity and robustness, according to USP guidelines.

Different spectrophotometric and TLC-densitometric methods for determination of olmesartan medoxomil and hydrochlorothiazide and their degradation products

“…Olmesartan medoxomil and HCZ combination is very effective and useful in treatment of hypertension. OL and SAL are considered to be OLM and HCZ degradation products, respectively [2][3][4]. As drug degradation may appear into the pharmaceutical formulations during different processes of manufacturing, packing, or storage.…”

“…Olmesartan (OL) chemically is 5-(2-hydroxypropan-2-yl)-2-propyl-3-[ [4-[2-(2H-tetrazol-5yl)phenyl]phenyl]methyl]imidazole-4-carboxylic acid [1] ( Figure 1). It is a selective AT1 subtype angiotensin II receptor antagonist, and also it is considered as a hydrolytic degradation product for olmesartan medoxomil [2].…”

Three Different Chemometric Approaches Coupled With Uv Spectroscopy for Analysis of Amlodipine and Olmesartan in Presence of Their Acidic Degradation Products

“…. Further testing the purity of degradade by comparing the IR spectrum, UV spectrum, and mass spectrum of the produced degradade with the reported method (Moussa et al, 2010).…”

Development and Validation of Rp-HPLC Method for Estimation of Amlodipine Besylate, Olmesartan Medoxomil and Hydrochlorthiazide in Tablet Dosage Form

“…Some methods have been reported with combination with OLM [42][43][44][45][46] , metoprolol 47 , nebivolol hydrochloride 48,49 and HCZ 50,51 . Analytical methods for the estimation of OLM in bulk drug and their formulation include UV method 52,53 and HPLC 54,55 , stability indicating HPLC 56,57 and some of the methods that have been for HCZ [58][59][60][61][62][63] . HCZ is official in IP 2 and USP 3 .…”