Development of a New UPLC Method for Simultaneous Determination of Valsartan, Amlodipine Besylate, and Hydrochlorothiazide Pharmaceutical Products

Abstract

Summary.A new ultra-performance liquid chromatography method for the simultaneous determination of valsartan, amlodipine besylate, and hydrochlorothiazide in pharmaceutical formulations has been developed. Chromatographic separation was achieved within 1 min on a sub-2 μm RP18 column using an isocratic mode mobile phase consisting of a mixture of methanol and phosphate buffer (0.05 M, pH 3 ± 0.05) in the ratio 70:30 (v/v). The flow rate was set at 0.3 mL min −1 with a detection wavelength of 239 nm. The method was validated over the concentration ranges from 6.5 to 15.0 μg mL −1 for hydrochlorothiazide, from 5.0 to 12 μg mL −1 for amlodipine besylate and from 76.5 to 178.5 μg mL −1 for valsartan. Calibration plots were linear for valsartan, amlodipine besylate, and hydrochlorothiazide with a correlation coefficient greater than 0.99. Relative variation coefficients for repeatability and reproducibility were less than 3.0%. Recoveries from standard addition essay of individual component in pharmaceutical formulations were varied from 97.0% to 102.0%. The proposed method was successfully applied for the determination of valsartan, amlodipine besylate, and hydrochlorothiazide in pharmaceutical formulations with recoveries with respect to label amount in pharmaceutical formulations that varied from 98.0% to 102.9%. The low flow rate, short analysis time, and simple mobile phase composition make the method cost effective, rapid, nontedious, and successfully employed for simultaneous determination of these drugs in commercial pharmaceutical products.

Development and validation of a rapid HPLC method for multiresidue determination of erythromycin, clarithromycin, and azithromycin in aquaculture fish muscles

“…The optimized method was then validated for the three studied macrolides with MRL 200 μg/kg, according to European Union decision [16]. The specificity was proved by studying the interference between analytes and blank samples at the elution times [17]. The linearity of the method was studied with nine different calibration levels of mixed standard solution containing 1.2-2.8 μg/mL of each macrolide.…”

Sustainable chromatographic quantitation of multi-antihypertensive medications: application on diverse combinations containing hydrochlorothiazide along with LC–MS/MS profiling of potential impurities: greenness and whiteness evaluation

“…The literature survey revealed several separation-based methods for resolving the studied antihypertensive drugs either in single or combined dosage forms. The mixture of HCT, VAL and AML has been recently analyzed by electrophoresis [ 17 ], high performance thin layer chromatography (HPTLC) [ 18 – 21 ], high performance liquid chromatography (HPLC) [ 22 – 26 ], LC–MS/MS [ 27 – 29 ] and ultra-performance liquid chromatography (UPLC) [ 30 , 31 ] methods. While a mixture of HCT, ATN and AMI has been determined lately by capillary electrophoresis [ 32 ], HPTLC [ 33 ], and HPLC [ 34 – 36 ] methods.…”

Eco-friendly spectrophotometric evaluation of triple-combination therapies in the treatment strategy of patients suffering from hypertension during coronavirus pandemic – Spectralprint recognition study

“…Literatures review for these triple antihypertensive formulations including spectrophotometry [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , chromatography [16] , [17] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] and electrochemical methods [34] , [35] .…”