Validated RP-HPLC method for the simultaneous determination of amlodipine besylate, valsartan, and hydrochlorothiazide in bulk and in pharmaceutical formulation

Abstract

A reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous estimation of amlodipine besylate (AMB), valsartan (VAL), and hydrochlorothiazide (HCT) in pharmaceutical formulation using RP-C 18 column. The mobile phase (acetonitrile:methanol:50 mM phosphate buffer adjusted to pH 3 with orthophosphoric acid) was pumped at a flow rate of 1.0 mL min −1 in the ratio of 20:50:30% v/v and the eluents were monitored at 239 nm. Linearity was obtained in the concentration range of 0.5-5 μg mL −1 for AMB, 4-40 μg mL −1 for VAL, and 1-10 μg mL −1 for HCT. The method was validated as per International Conference on Harmonization (ICH) guidelines and statistically. The method was validated for accuracy and precision. For precision, the coefficient of variance (COV) was found to be 0.3794, 0.1703 and 0.0578, and for accuracy, it was found to be 0.6351, 0.7688 and 1.1305 for AMB, VAL, and HCT, respectively. The COV values for all the drugs were found to be less than 2%, indicating high degree of precision and accuracy of the proposed highperformance liquid chromatographic (HPLC) method. Owing to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method can be applied for determining AMB, VAL, and HCT in bulk and in pharmaceutical dosage form.

Synchronized separation of seven medications representing most commonly prescribed antihypertensive classes by using reversed‐phase liquid chromatography: Application for analysis in their combined formulations

“…The reported method for simultaneous determination of HCZ, AML, and ALS ternary mixture was based on an ion pairing RP‐LC–UV technique using acetonitrile/25 mM octane sulfonic acid sodium salt monohydrate in water (60:40, v/v) as the mobile phase , whereas the proposed method is more conventional for analysis of that mixture. Regarding the reported method for simultaneous determination of HCZ, AML, and VAL, it was based also on a RP‐LC technique using acetonitrile, methanol and 50 mM phosphate buffer adjusted to pH 3 with orthophosphoric acid as the mobile phase in the ratio of 20:50:30, v/v and the eluents were monitored at 239 nm . On the other hand, Erturk et al reported a RP‐LC method for simultaneous determination of HCZ and MXP in tablets which was performed using a mobile phase consisting of acetonitrile and phosphate buffer (pH 4) (50:50, v/v) .…”

“…So, it is necessary to develop a validated analytical method for assay of the cited drugs in combination with HCZ in their pharmaceutical preparations. A literature review revealed some published methods for simultaneous determination of one or more of the studied drugs in combination with HCZ using different analytical techniques such as LC–UV: ATN , VAL , MXP , ALS , AML , CND , LC–MS/MS: ATN , VAL , CND , UV spectroscopy: ATN , VAL , MXP , ALS , AML , CND , and CE: ATN , VAL , ALS , CND . To the best of our knowledge there is no method to separate the seven cited drugs.…”

Spectrophotometric determination of tadalafil in pure and dosage forms

“…These methods do not involve procedural steps and do not take more operator time and exper- tise like HPLC and other methods. In terms of simplicity, rapidity, sensitivity, expense and free from interference by common additives and excipients, the methods could be considered superior in comparison with the previously reported methods, especially with those based on chromatography [3][4][5][6][7] or other reported spectrophotometric methods [9][10][11]. The reagents utilized in the proposed methods are cheaper, readily available and the procedures do not involve any critical reaction conditions or tedious sample preparation.…”

“…Extensive literature survey revealed that the determination of TDF in pure and dosage forms are not official in any pharmacopoeia and therefore, require much more investigation. Several analytical methods that have been reported for the estimation of TDF in biological fluids or pharmaceutical dosage forms include liquid chromatography [3][4][5][6][7], densitometry [8] and spectrophotometry [9][10][11].…”

New HPLC Method with Experimental Design and Fluorescence Detection for Analytical Study of Antihypertensive Mixture, Amlodipine and Valsartan

“…HPTLC and HPLC methods were also elaborated and validated in the range of official requirements [4,5,[7][8][9][10]. Similar chromatographic methods exist for amlodipine and valsartan in triple drug combinations [11][12][13][14][15][16].…”