RP-LC Simultaneous Determination of Nebivolol Hydrochloride and Amlodipine Besilate in Bi-Layer Tablets

Joshi, Sneha J.; Karbhari, Pradnya A.; Bhoir, Suvarna I.

doi:10.1365/s10337-009-1165-1

Cited by 11 publications

(6 citation statements)

References 8 publications

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“…Different analytical methods have been developed for the study of stressed degradation behavior of pharmaceutical active substances and amlodipine besylate including spectrophotometric method [17], HPTLC [18,19], HPLC [20][21][22][23], RP-HPLC [24][25][26][27], UPLC [28], CE [29] and LC-2D-NMR/LC-MS [30]. Forced degradation studies show that amlodipine is degrading slowly under thermal stress conditions [16], degrading faster under photo stress -more rapidly under 366 than under 254 nm [10] and even more under acidic, alkaline and oxidative stress conditions [21].…”

mentioning

confidence: 99%

Investigation of forced and total degradation products of amlodipine besylate by liquid chromatography and liquid chromatography-mass spectrometry

Stoiljković

Jadranin

Đurić

et al. 2014

CI&CEQ

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Article Highlights• Amlodipine besylate stock solutions were subjected to stressed conditions • Acid and alkali hydrolysis, chemical oxidation and photodegradation were used • Electrochemical degradation by cyclic voltammetry was also studied • LCMS was used for the investigation of the degradation products • Total degradation of amlodipine besylate was achieved in 5 mol/L NaOH at 80 °C for 6 h Abstract An isocratic, reversed-phase liquid chromatographic method was applied for the investigation of the degradation products of amlodipine besylate under stressed conditions in solution. Amlodipine besylate stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation and photodegradation, as well as to the electrochemical degradation by cyclic voltammetry in 0.05 mol/L NaHCO 3 on gold electrode. The total degradation of amlodipine besylate was achieved in 5 mol/L NaOH at 80 °C for 6 h and the compound with molecular formula C 15 H 16 NOCl was identified as a main degradation product. Under acidic (5 mol/L HCl at 80 °C for 6 h) stress conditions 75.2% of amlodipine besylate degradation was recorded. Oxidative degradation in a solution of 3% H 2 O 2 :methanol 80:20 at 80 °C for 6 h showed that amlodipine besylate degraded to 80.1%. After 14 days of expose in photostability chamber amlodipine besylate solution showed degradation of 32.2%. In electrochemical degradation, after 9 h of cyclization the beginning of amlodipine oxidation was shifted for 200 mV to more negative potentials, with the degradation of 66.5%. Mass spectrometry analysis confirmed the presence of dehydro amlodipine derivate with molecular formula C 20 H 23 N 2 O 5 Cl in oxidative and acidic conditions, while in electrochemical degradation was detected in traces.Keywords: amlodipine besylate, forced degradation, reversed phase liquid chromatography, liquid chromatography-mass spectrometry.Amlodipine, R,S-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine is a calcium channel blocking agent with a long duration of action, widely used against hypertension and angina [1,2]. It was

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confidence: 99%

Investigation of forced and total degradation products of amlodipine besylate by liquid chromatography and liquid chromatography-mass spectrometry

Stoiljković

Jadranin

Đurić

et al. 2014

CI&CEQ

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“…The results show that the proposed method is 3–24 times more sensitive than the reported chromatographic methods for the simultaneous determination of NEB and AML. Moreover, the proposed method is 2–9 times more sensitive than the reported spectrophotometric methods for NEB and AML, respectively. This high sensitivity makes the proposed method superior to the chromatographic and spectrophotometric methods reported in the literature.…”

Section: Resultsmentioning

confidence: 88%

“…A literature survey revealed that several of the analytical methods published for the determination of a combination of NEB and AML rely on the use of spectrophotometry , HPLC and HPTLC .…”

Section: Introductionmentioning

confidence: 99%

Second‐derivative synchronous spectrofluorimetric determination of nebivolol hydrochloride and amlodipine besylate in their combined dosage form

et al. 2015

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A rapid, simple, accurate and highly sensitive spectrofluorimetric method was developed for the simultaneous analysis of nebivolol hydrochloride (NEB) and amlodipine besylate (AML). The method was based on measuring the synchronous fluorescence intensity of the drugs at Δλ = 40 nm in methanol. Various experimental parameters affecting the synchronous fluorescence of the studied drugs were carefully studied and optimized. The calibration plots were rectilinear over concentration ranges of 0.05-1.5 µg/mL and 0.5-10 µg/mL for NEB and AML with limits of detection (LOD) of 0.010 and 0.051 µg/mL and limits of quantitation (LOQ) of 0.031 and 0.156, respectively. The peak amplitudes ((2) D) of the second derivative synchronous fluorimetry (SDSF) were estimated at 282 nm for NEB and at 393 nm for AML. Good linearity was obtained over the concentration ranges. The proposed method was successfully applied to the determination of the studied compounds in laboratory-prepared mixtures, commercial single and laboratory-prepared tablets. The results were in good agreement with those obtained using the comparison method. The mean percent recoveries were found to be 100.12 ± 0.77 and 99.91 ± 0.77 for NEB and AML, respectively.

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“…Several analytical methods have been reported for the determination of AML in pharmaceutical formulations and/or biological fluids. These methods include spectrophotometry [19][20][21], spectrofluorimetry [22,23], anodic stripping voltammetry [24,25], HPLC [26][27][28][29][30][31], HPTLC [32], capillary electrophoresis [33] and micellar electrokinetic chromatography [34].…”

Section: Introductionmentioning

confidence: 99%

Multivariate Versus Classical Univariate Calibration Methods for Spectrofluorimetric Data: Application to Simultaneous Determination of Olmesartan Medoxamil and Amlodipine Besylate in their Combined Dosage Form

Darwish

Backeit

2012

J Fluoresc

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Olmesartan medoxamil (OLM, an angiotensin II receptor blocker) and amlodipine besylate (AML, a dihydropyridine calcium channel blocker), are co-formulated in a single-dose combination for the treatment of hypertensive patients whose blood pressure is not adequately controlled on either component monotherapy. In this work, four multivariate and two univariate calibration methods were applied for simultaneous spectrofluorimetric determination of OLM and AML in their combined pharmaceutical tablets in all ratios approved by FDA. The four multivariate methods are partial least squares (PLS), genetic algorithm PLS (GA-PLS), principal component ANN (PC-ANN) and GA-ANN. The two proposed univariate calibration methods are, direct spectrofluorimetric method for OLM and isoabsorpitive method for determination of total concentration of OLM and AML and hence AML by subtraction. The results showed the superiority of multivariate calibration methods over univariate ones for the analysis of the binary mixture. The optimum assay conditions were established and the proposed multivariate calibration methods were successfully applied for the assay of the two drugs in validation set and combined pharmaceutical tablets with excellent recoveries. No interference was observed from common pharmaceutical additives. The results were favorably compared with those obtained by a reference spectrophotometric method.

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RP-LC Simultaneous Determination of Nebivolol Hydrochloride and Amlodipine Besilate in Bi-Layer Tablets

Cited by 11 publications

References 8 publications

Investigation of forced and total degradation products of amlodipine besylate by liquid chromatography and liquid chromatography-mass spectrometry

Investigation of forced and total degradation products of amlodipine besylate by liquid chromatography and liquid chromatography-mass spectrometry

Second‐derivative synchronous spectrofluorimetric determination of nebivolol hydrochloride and amlodipine besylate in their combined dosage form

Multivariate Versus Classical Univariate Calibration Methods for Spectrofluorimetric Data: Application to Simultaneous Determination of Olmesartan Medoxamil and Amlodipine Besylate in their Combined Dosage Form

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