HPLC method development for the simultaneous analysis of amlodipine and valsartan in combined dosage forms and in vitro dissolution studies

Abstract

A simple, rapid and reproducible HPLC method was developed for the simultaneous determination of amlodipine and valsartan in their combined dosage forms, and for drug dissolution studies. A C18 column (ODS 2, 10 &#956;m, 200 x 4.6 mm) and a mobile phase of phosphate buffer (pH 3.6 , 0.01 mol L-1):acetonitrile: methanol (46:44:10 v/v/v) mixture were used for separation and quantification. Analyses were run at a flow-rate of 1 mL min-1 and at ambient temperature. The injection volume was 20 &#956;L and the ultraviolet detector was set at 240 nm. Under these conditions, amlodipine and valsartan were eluted at 7.1 min and 3.4 min, respectively. Total run time was shorter than 9 min. The developed method was validated according to the literature and found to be linear within the range 0.1 - 50 &#956;g mL-1 for amlodipine, and 0.05 - 50 &#956;g mL-1 for valsartan. The developed method was applied successfully for quality control assay of amlodipine and valsartan in their combination drug product and in vitro dissolution studies.<br>Desenvolveu-se método de HPLC rápido e reprodutível para a determinação simultânea de anlodipino e valsartana em suas formas de associação e para os estudos de dissolução dos fármacos. Utilizaram-se coluna C18 (ODS 2, 10 &#956;m, 200 x 4,6 mm) e fase móvel tampão fosfato (pH 3,6, 0,01 mol L-1):acetonitrila: metanol para a separação e a quantificação. As análises foram efetuadas com velocidade de fluxo de 1 mL min-1 e à temparatura ambiente O volume de injeção foi de 20 &#956;L e utilizou-se detector de ultravioleta a 240 nm. Sob essas condições, anlodipino e valsartana foram eluídas a 7,1 min e 3,4 min, respectivamente. O tempo total de corrida foi menor que 9 min. O método desenvolvido foi validado de acordo com a literatura e se mostrou linear na faixa de 0,1-50 &#956;g mL-1 para anlodipino e de 0,05-50 &#956;g mL-1 para valsartana. O método desenvolvido foi aplicado com sucesso para ensaios de controle de qualidade de associações de anlodipino e valsartana e nos estudos de dissolução in vitro

Simple RP-HPLC method for determination of triple drug combination of valsartan, amlodipine and hydrochlorothiazide in human plasma

“…There are also re- ports of methods for simultaneous estimation of VAL and HCT in human plasma (14) and VAL and AML (15) in rat lever perfusion, but no method has been reported so far for simultaneous estimation of VAL, AML and HCT in human plasma. Hence, we aimed to develop and validate a simple RP-HPLC method for the triple drug combination of valsartan, amlodipine and hydrochlorothiazide in human plasma that could be used for pharmacokinetic studies and therapeutic drug monitoring.…”

Quantitative Determination of Amlodipine Besylate, Losartan Potassium, Valsartan and Atorvastatin Calcium by HPLC in their Pharmaceutical Formulations

“…BP described a RP-HPLC method for assay of Amlodipine besylate and potentiometric titrations for assay of Atorvastatin calcium, Losartan potassium and Valsartan [3]. Several methods have been published for simultaneous determination of studied drugs in their combinations with each other, these methods depends on different analytical technique like Spectrophotometry [4][5][6][7][8][9][10][11], Spectrofluorimetry [12][13][14], Capillary Electrophoresis [15][16][17][18], HPTLC and TLC [19][20][21] and HPLC coupled with UV detector [21][22][23][24][25][26][27][28][29], fluorescence detector [30] and mass spectrometer detector [31][32][33][34]. Our scope is development of a validated analytical method for assay of these drugs in combination with each other in its pharmaceutical preparations and it should be characterized by a simplicity, accuracy, preciseness and sensitivity.…”

Compatibility and stability of valsartan in a solid pharmaceutical formulation

“…Several HPLC-UV methods for the determination of VAL have been described in the literature (Agrahari et al, 2009;Celebier et al, 2010;Krishnaiah et al, 2010) but have not been used to test VAL's stability and compatibility with excipients.…”

“…To minimize or prevent hypertension, adequate diet and physical exercise are recommended. Many different medicines can be used to treat high blood pressure, including angiotensin II receptor antagonists such as valsartan (VAL), also known as N- (1-oxopentyl)-N-[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine (Celebier et al, 2010). This medication is generally prescribed in high doses (approximately 40 to 320 mg daily) for continuous use.…”