High-Performance Liquid Chromatographic Method for Quantitative Determination of Amlodipine in Human Plasma and Pharmaceutical Dosage Form and its Application to Pharmacokinetic Studies

Abstract

An accurate, sensitive, and reproducible high-performance liquid chromatographic method for the quantitation of amlodipine besylate in human plasma has been developed and validated. The drug, internal standard, and major metabolite were eluted from a C(18) hypersil HyPurity column (3 microm, 3.9 mm i.d. x 150 mm) at room temperature with a mobile phase consisting of acetonitrile-potassium dihydrogen phosphate buffer (0.05 M) and acetic acid (62:38:0.1) with the pH adjusted to 3.5 using phosphoric acid. The flow-rate was 1.8 mL/min. The limit of detection was 1.0 ng/mL, and the limit of quantification of amlodipine besylate in plasma was 10 ng/mL. The intra- and inter-day precisions showed coefficients of variation ranging from 5.98-11.4% and from 5.60-11.74%, respectively at three different levels of concentration. The averages of the absolute and relative recoveries were found to be 96.74-98.51% and 95.96-100.71%, respectively. Stability studies showed that amlodipine besylate is stable for at least 2 months in plasma after freezing at -20 degrees C. The method was successfully applied for a pharmacokinetic study and for the determination of commercial amlodipine tablet content.

Development and Validation of HPLC Method for Simultaneous Determination of Amlodipine, Valsartan, Hydrochlorothiazide in Dosage Form and Spiked Human Plasma

“…However, there is very few analytical methods reported for the simultaneous analysis of these drugs in a combined dosage formulation [3,4]. The reported methods are UV spectrophotometric [5][6][7][8][9], Spectrofluorimetric [10] HPLC [11][12][13][14][15][16][17][18][19][20][21][22][23][24], HPTLC [25,26], capillary electrophoresis [27][28][29][30] and electrochemical [31][32][33][34] methods.…”

The Comparison of Doxycycline Residue in the Meat of Broiler Chickens Administered in Feed and Water

“…This research in line with Wijayanti et al (2009) who revealed that the elimination half life (T1/2) of doxycycline in the muscle was 55.5 hours and the period of elimination time was long. Alsarra et al (2005) found that the T1/2 of doxycycline in plasma was 16-17 hours given by oral formulation. The long elimination time and continuous administration will cause the persistence of drug level in high concentration for a long period.…”

An Improved Rapid HPLC Method for the Separation of Five Anti-Hypertensive Agents Using C18 Column: Application to Hydrochlorothiazide Determination in Bulk and Tablet Dosage Form

“…Literature survey reveals that for the determination of above said five anti-hypertensive agents in biological fluids like plasma, blood, urine and pharmaceutical dosage forms by spectrophotometry [1][2][3][4] , spectrofluorimetry [5] , TLC [6][7] , HPTLC [8] , High Performance Liquid Chromatography (RP-HPLC) with UV detection [9][10][11][12][13][14][15][16][17][18] , fluorimetric detection [19] , ion-pair HPLC [20] , RP-UPLC [21] and Liquid Chromatography-Mass Spectrometry [22][23] , Capillary electrophoresis [24] .In fact there is a need for the development of a novel, simple, rapid, efficient RP-HPLC analytical method with reproducibility for determination of HCT in bulk and pharmaceutical dosage forms. A group of five anti-hypertensive drugs investigated in the present study are listed in Figure 1.…”