Validated Rp-HPLC Method and Unique Mobile Phase for the Simultaneous Estimation of Amlodipine Besylate and Valsartan From Solid Dosage Form and Rosuvastatin and Valsartan From Bulk

Gk, Dyade; Rl, Sawant

doi:10.22159/ajpcr.2019.v12i4.31878

Cited by 5 publications

(1 citation statement)

References 13 publications

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“…-L-valine [1][2][3][4] . Techniques such as RP-HPLC methods [19][20] , photodegradation study method 21 , bio-analytical chromatographic methods [22][23] , synchronous spectrofluorimetric bio-analytical method 24 and stability indicating UPLC method 25 have been reported for estimation of VAL alone or in combination with other drugs. One of the more recently introduced statins, Rosuvastatin (RV), chemically 7-[4-(4-fluorophenyl) -6 -(1methylethyl) -2 -(methyl-methylsulfonyl -amino) -pyrimidin-5-yl] 3, 5-dihydroxy-hept-6-enoic acid is HMG-CoA reductase inhibitors 1-3 .…”

mentioning

confidence: 99%

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2023

IJPSR

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A reverse phase high-performance liquid chromatographic bio analytical Technique (RP-HPLC) was developed and validated as per ICH 2019, US FDA 2018 guidelines for the quantification of amlodipine besylate, Rosuvastatin and Valsartan in human plasma using RP -C18 column. The mobile phase in composition (acetonitrile: water in the ratio 75:25% v/v, pH adjusted to 4.0 with acetic acid) was pumped and run at a flow rate of 0.8 ml/min, and for monitoring of eluents, a detector was set at wavelength 245 nm. The precipitation method was employed for the separation of the analyte from the plasma. A calibration curve was generated from the response and respective conc of standard solutions in the Concrange of LLOQ to ULOQ. The method was studied and validated per regulatory guidelines for selectivity, specificity, accuracy, precision, and stability study. Statistical data of the calibration curve of these drugs in the biological matrix was found within the prescribed limit. Results of accuracy and precision of quality control samples of these combined drugs were found (104.25 to 107.62 as % nominal conc. and 2.633 to 9.474 as % CV) for amlodipine, (101.01 to 106.45 as % nominal conc. and 4.431 to 13.786 as % CV) for rosuvastatin and (99.91 to 106.03 as % nominal conc. and 2.668 to 12.434 as % CV) for valsartan respectively. The developed bioanalytical method is simple: free from solvent-solvent extraction and solid phase extraction, precise, accurate and consumes less solvent due to less run time. The method suits for quantification of these drugs in plasma is henceforth applied for bioequivalence and bioavailability study in real clinical samples.INTRODUCTION: Amlodipine besylate (AD), 2 -[(2 -amino ethoxy) -methyl] -4 -(2 -chloro phenyl) -1, 4 -dihydro -6 -methyl -3, 5 -pyridine dicarboxylic acid 3 -ethyl -5 -methyl ester benzene sulfonate, is a potent dihydro calcium channel blocker 1-4 .

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confidence: 99%

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2023

IJPSR

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Box‒Behnken design-assisted development of an eco-friendly thin-layer chromatography‒densitometry method for the quantification of amlodipine besylate, metoprolol succinate, and telmisartan in synthetic mixture using AGREE tool

Patel,

Macwan,

Prajapati

et al. 2023

JPC-J Planar Chromat

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Smart mathematically filtered UV spectroscopic methods for quality assurance of rosuvastatin and valsartan from formulation

Attimarad,

Ahmed,

Nair

et al. 2024

Open Physics

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Valsartan and rosuvastatin together in a binary form have been utilized to reduce hypertension and hyperlipidemia to control cardiovascular complications. This study depicts the simple three mathematically manipulated UV spectroscopic techniques for the estimation of rosuvastatin and valsartan in the formulation. The first method is simple UV absorption at 310 nm by RST and the first derivatization method for VTN. Determining the magnitude difference of a ratio spectrum at two identified wavelengths is the second approach, and determination of the magnitude of the first derivatives of the ratio spectra of RST and VTN constitute the third technique. The selection of wavelengths, divisor concentrations, and peak amplitudes were optimized and validated. The straight line was constructed in the range of 1–30 and 2–25 µg/ml for RST and VST by the normal and first derivatization method. By using the magnitude difference and magnitude of first derivative ratio spectra approaches, the concentrations of 1–12 and 2–25 µg/ml for RST and VTN, respectively, displayed a straight line. The limit of quantification was less than 1 µg/ml for RST and less than 2 µg/ml for VTN. It was eventually found that the accuracy, expressed as a percentage recovery, ranged between 98.94 and 99.55% for RST and 100.36 and 101.08% for VTN. The % RSD did not exceed 1.82 and 1.91 for RST and VTN, respectively. The three techniques were used to accurately measure RST and VTN in their binary formulations and physically mixed solutions, and the results were statistically compared to the previously published HPLC technique. The outstanding recovery achieved by using the authentic standard addition approach validated the methods’ supplemental accurateness. The Analytical Greenness and Red Green Blue procedures verified the eco-friendliness of the suggested UV spectroscopic approaches, which were also found to be superior to the documented HPLC methods.

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Validated Rp-HPLC Method and Unique Mobile Phase for the Simultaneous Estimation of Amlodipine Besylate and Valsartan From Solid Dosage Form and Rosuvastatin and Valsartan From Bulk

Cited by 5 publications

References 13 publications

Untitled

Untitled

Box‒Behnken design-assisted development of an eco-friendly thin-layer chromatography‒densitometry method for the quantification of amlodipine besylate, metoprolol succinate, and telmisartan in synthetic mixture using AGREE tool

Smart mathematically filtered UV spectroscopic methods for quality assurance of rosuvastatin and valsartan from formulation

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