Effect of Non-Aqueous and Buffered Mobile-Phase Composition on the Retention of Ivabradine

Pikuł, Piotr; Nowakowska, Joanna; Ciura, Krzesimir

doi:10.1080/10826076.2013.825844

Cited by 5 publications

(4 citation statements)

References 11 publications

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“…In the previously reported methods, ivabradine was determined using different TLC system which include aqueous (methanol: water and acetonitrile: water) and non-aqueous (methanol: acetonitrile and methanol: dimethyl sulfoxide) as well as non-aqueous with buffered as binary mobile phases with various concentrations range. Many high performance TLC stationary phase were tired: Kieselgel 60 F 254 S, Kieselgel 60 CN F 254 S, Kieselgel 60 NH 2 F 254 S, RP-8 F 254 S and RP-18 F 254 S. Moreover, the association between the log (1/retention factor) values, molecular polarizabilities of solvents and thermodynamic dependence were studied to analyze the effect of the electrostatic interaction to notice if there is influence on retention factor of ivabradine [ 17 , 18 ]. It is worthy to mention that up till now there is no previously reported HPTLC method for simultaneous determination of ivabradine and metoprolol.…”

Section: Introductionmentioning

confidence: 99%

Comparative HPTLC study for simultaneous determination of ivabradine and metoprolol using UV and fluorescence detectors

Rizk,

Mowaka,

Mohamed

et al. 2023

BMC Chemistry

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New, simple, accurate, sensitive and validated high performance thin layer chromatographic (HPTLC) method coupled with UV absorbance mode and fluorescence (FL) detectors which were used for simultaneous determination of ivabradine (IVA) and metoprolol (MET) in their bulk and pharmaceutical dosage form using TLC silica 60 F254 plates and non-fluorescent TLC silica gel 60 plates. The developing system was chloroform: methanol: formic acid: ammonia (8.5:1.5:0.2:0.1, v/v). Desnitometric analysis in UV absorbance mode was set at λ = 275 nm. While, fluorescence mode was performed with excitation at 260 nm for quantitative simultaneous determination of IVA and MET using optical filter K320. The retention factors values were 0.45 ± 0.05 and 0.89 ± 0.01 of IVA and MET, respectively. UV absorbance mode, linearity was 50.0–600.0 ng/band for IVA and 50.0–900.0 ng/band for MET. For fluorescence mode, the linearity ranges were 18.0–400.0 ng/band and 50.0–550.0 ng/band for IVA and MET; respectively. ICH guidelines were followed in respect to linearity and range, accuracy, precision and selectivity, limit of detection (LOD), limit of quantitation (LOQ) and robustness. The analytical eco-scale, green analytical procedure index (GAPI) and analytical greenness metric tools were used to assess the suggested method. The quantitative proposed method results showed there was no statistically significant difference at 95% confidence when compared to the reported method of high performance liquid chromatography (HPLC).

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Section: Introductionmentioning

confidence: 99%

Comparative HPTLC study for simultaneous determination of ivabradine and metoprolol using UV and fluorescence detectors

Rizk,

Mowaka,

Mohamed

et al. 2023

BMC Chemistry

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“…A lowered pacemaker current ensures a reduced heart rate, dependent on the drug dosage [4]. Though sufficient information is available about the structure, properties [5, 6, 7], and estimation techniques [8, 9, 10, 11, 12, 13, 14, 15] of Ivabradine; there is little information available about its impurity molecule IVA-9 (Fig. 1a & 1b).…”

Section: Introductionmentioning

confidence: 99%

Computational and spectral studies of 3,3'-(propane-1,3-diyl)bis(7,8-dimethoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin-2-one)

Kumar

Bhaskar

2019

Heliyon

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Detection and qualification of unknown impurities during commercial drug synthesis have been mandated by the regulatory authorities. 3,3'-(propane-1,3-diyl)bis(7,8-dimethoxy-1,3,4,5-tetrahydro-2H-benzo [d]azepin-2-one) in short IVA-9, is one such process-related impurity formed during the synthesis of cardiotonic drug Ivabradine. The structure and properties of this molecule have not been explored yet. A suggestive reaction route for the chance formation of IVA-9 during the commercial synthesis of parent drug molecule has been reported in this article. Further, the optimized geometry and vibrational studies have been computed using Gaussian 09. Experimental FTIR scan has also been performed and values show satisfactory consilience with the computational data. The frontier orbital energies and energy band gaps of the reaction fragments and products were computed. The evaluation of ADME parameters such as absorption, distribution, metabolism, and excretion are performed using SwissADME tool to assess the drug-likeness and medicinal chemistry friendliness. Six physiochemical parameters namely flexibility, lipophilicity, size, polarity, solubility and saturation and their critical limits are depicted using the bioavailability radar of the programme to provide insights into pharmacokinetic properties such as human gastrointestinal absorption (HIA), blood-brain-barrier (BBB) permeability, total polar surface area (TPSA) and inhibitor action to important cytochromes etc.

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“…It's efficiency in treating angina pectoris and myocardial ischemia, without any negative hemodynamic effects, has been described [1]. Estimation of ivabradine has been achieved in the past by high-performance liquid chromatography [2][3][4], thin layer chromatography [5][6][7][8], liquid chromatography with spectrometry [9][10][11] and spectrophotometry [12,13]. The polymorphism, co-crystallization [14], crystal chemistry [15] and sustained release studies [16] of ivabradine were reported.…”

Section: Introductionmentioning

confidence: 99%

Spectroscopic and Volumetric Techniques for the Estimation of Ivabradine Impurity 3,3'-(Propane-1,3-Diyl)bis(7,8-Dimethoxy-1,3,4,5-Tetrahydro-2h-Benzo[d]azepin-2-One)

Kumar

Bhaskar

2019

Int J App Pharm

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Objective: Two simple and sensitive techniques - one spectrophotometric and one titrimetric- have been developed for the determination of 3,3'-(propane-1,3-diyl)bis(7,8-dimethoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin-2-one) commonly known as ivabradine impurity-9 (IVA-9). Methods: The spectrophotometric method is based on the oxidation of drug impurity by excess cerium (IV) sulphate in acidic medium and the subsequent reaction of the remaining Ce(IV) with a known amount of ferrous ammonium sulphate. The resultant ferric ion is then made to react with thiocyanate in acid medium to form a brown coloured complex which is analyzed spectrophotometrically against the reagent blank. In the volumetric method, the un-reacted Ce(IV) is titrated against standard ferrous ammonium sulphate to estimate the quantity of IVA-9. Results: The colored complex showed an absorption maximum at 479 nm when measured spectrophotometrically. The stated methods are validated statistically using the International Council for Harmonization guidelines-ICH Q2(R1) for precision and accuracy. The method showed a linear response from 0.5 to 100µg/ml with a correlation coefficient of 0.9985 Conclusion : No estimation techniques have been reported to date for the determination of this molecule. The proposed techniques may be used for the routine quantification in its pure form and also in presence of its parent drug molecule Ivabradine.

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Effect of Non-Aqueous and Buffered Mobile-Phase Composition on the Retention of Ivabradine

Cited by 5 publications

References 11 publications

Comparative HPTLC study for simultaneous determination of ivabradine and metoprolol using UV and fluorescence detectors

Comparative HPTLC study for simultaneous determination of ivabradine and metoprolol using UV and fluorescence detectors

Computational and spectral studies of 3,3'-(propane-1,3-diyl)bis(7,8-dimethoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin-2-one)

Spectroscopic and Volumetric Techniques for the Estimation of Ivabradine Impurity 3,3'-(Propane-1,3-Diyl)bis(7,8-Dimethoxy-1,3,4,5-Tetrahydro-2h-Benzo[d]azepin-2-One)

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