Rapid Simultaneous Determination of Olmesartan, —Amlodipine and Hydrochlorothiazide in Combined Pharmaceutical Dosage form by Stability-Indicating Ultra Performance Liquid Chromatography

Abstract

A simple, precise and rapid stability-indicating ultra-performance liquid chromatography (UPLC) method was developed for the simultaneous quantitative determination of Olmesartan, Amlodipine and Hydrochlorothiazide from their innovative Pharmaceutical combination drug product, with the presence of degradation products. It involved a 50 mm × 2.1 mm, 1.8 µm Phenyl column. The separation was achieved on simple gradient method. The mobile phase A contains a mixture of sodium perchlorate buffer pH 3.2(0.053M): acetonitrile in the ratio 90:10, v/v, and mobile phase B contains a mixture of sodium perchlorate buffer pH 3.2(0.053M): acetonitrile in the ratio 10:90, v/v. The flow rate was 0.7 mL•min-1 and column temperature was maintained at 55˚C.The gradient program (T/%B) was set as 0/10, 2/50, 4/80, and 6.0/10. The detector wavelength was 271 nm for Hydrochlorothiazide, 215 for Olmesartan and 237 nm for Amlodipine. The retention times of Olmesartan, Amlodipine, and Hydrochlorothiazide are 3.5, 3.3 and 0.9 minutes; respectively. The total runtime was 6.0 minutes within which three active compounds and their degradation products were separated. The described method was validated with respect to system suitability, specificity, linearity, precision and accuracy. The precision of the assay method was evaluated by carrying out six independent assays of Olmesartan, Amlodipine, and Hydrochlorothiazide (0.004 mg•mL-1 , 0.001 mg•mL-1 , 0.0025 mg•mL-1). The accuracy of the method was evaluated in triplicate at three concentration levels, i.e. 50%, 100%, and 150% of target test concentration. The described method was linear over the range, 2 to 6 µg•mL-1 for Olmesartan, 0.5 to 1.5 µg•mL-1 Amlodipine and 1.25 to 3.75 µg•mL-1 for Hydrochlorothiazide. The method is fast and is suitable for high-throughput analysis of the drug and one can analyze about 240 samples per working day, facilitating the processing of large-number batch samples.

Distribution of Iodine125 Labeled Parathion and the Protective Effect of Dried Banana Peel in Experimental Mice

“…For more clarification HPLC was used, in which the retention time (Rt) of free iodide and [ 125 I] PA were after 3.5 and 5 min, respectively as shown in (Figure 2), whereas UV of olmesartan medoxomil was after 3.5 min. [31][32][33].…”

LC–MS/MS and in silico analysis of pharmaceutical impurities in a combination drug for hypertension

“…Several methods have been reported to simultaneously determine HCT, AML, and OML in combined dosage form by HPLC [19][20] and UPLC [21]. Additionally, we evaluated the related substances for each combination of HCT, AML, and OLM [1,22].…”

A Validated Stability-Indicating Liquid Chromatographic Method for the Simultaneous Determination of Amlodipine and Benazepril in Capsules Dosage Form

“…Few analytical methods for the determination of amlodipine besylate and benazepril hydrochloride in combined dosage forms including RP-HPLC [4][5][6], spectrophotometry [6,7] and HPTLC [8] have been reported. Several methods have been reported for the determination of amlodipine with other drugs by UV-spectrophotometry [9][10][11][12][13], dual wavelength spectrophotometry [14,15], derivative spectrophotometry [16,17], kinetic spectrophotometry [18], HPLC with UV detection [17,[19][20][21][22][23][24][25][26][27], HPLC with PDA detection [28][29][30], HPLC with fluorescence detection [31], spectrofluorimetry [32], HPTLC [33] and capillary electrophoresis [34] and amlodipine alone by visible spectrophotometry [35,36] and voltammetry [37] from pharmaceutical formulations. Benazepril hydrochloride has been determined either alone or with other drugs in pharmaceutical formulations by spectrophotometry [38][39][40][41][42], potentiometry [43], HPTLC [44] and HPLC…”