Determination of rupatadine in pharmaceutical formulations by a validated stability‐indicating MEKC method

Nogueira, Daniele Rubert; Sangoi, Maximiliano da Silva; Silva, Lucélia Magalhães da; Todeschini, Vítor; Dalmora, Sérgio Luiz

doi:10.1002/jssc.200800254

Cited by 16 publications

(16 citation statements)

References 17 publications

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“…The use of low concentrations levels of BGE and SDS contribute to raising the capillary and the equipment validity, due to the lower current generated. 26 The use of an IS is recommended to compensate injection errors and minor fluctuations of the migration time thereby improving the quantitative analysis. Thus, several drugs including nimesulide, losartan, hydrochlorothiazide, and salicylic acid were tested.…”

Section: Resultsmentioning

confidence: 99%

Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

et al. 2013

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Recebido em 24/2/12; aceito em 25/7/12; publicado na web em 11/12/12 A stability-indicating method using MEKC was validated for the analysis of olmesartan medoxomil in tablets. Successful separation was achieved using a fused silica capillary (40 cm x 50 μm i.d.); background electrolyte consisted of a combination of 10 mmol L -1 borate buffer and 5 mmol L -1 anionic detergent sodium dodecyl sulfate (95:5; v/v) pH 6.5; hydrodynamic mode at 50 mBar for 5 s; 25 kV separation voltage at 25 °C; and column temperature 25 °C with detection at 257 nm. The proposed method, validated following ICH guidelines, was applied to the determination of this antihypertensive with good results compared with an LC method.

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Section: Resultsmentioning

confidence: 99%

Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

et al. 2013

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“…24) Several drugs were investigated as IS before the beginning of the validation procedure. The substances tested were: rosiglitazone, butenafine, sitagliptine, hydrochlorothiazide, duloxetine, metoprolol, tetracycline, nimesulide, among others.…”

Section: Optimization Of the Electrophoretic Conditionsmentioning

confidence: 99%

Micellar Electrokinetic Chromatographic Method for Mianserin Hydrochloride and Analysis of Degradation Products by Mass Spectrometry

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Gobetti

Sangoi

et al. 2012

CHEMICAL & PHARMACEUTICAL BULLETIN

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A simple, stability-indicating micellar electrokinetic chromatography (MEKC) method was developed and validated for the analysis of mianserin hydrochloride in coated tablets. The method employed (hydroxymethyl)aminomethane (TRIS) 50 mM to which sodium dodecyl sulfate (SDS) 50 mM was added at pH 10.6 as the electrolyte and the voltage applied was 25 kV. The capillary used was 48.5 cm long (40.0 cm effective length and 50.0 µm i.d.) and the detection wavelength was 220 nm. Tetracycline was used as internal standard. The method was validated in accordance with the International Conference on Harmonization (ICH) requirements, which involved specificity, linearity, precision, accuracy and robustness. The stability-indicating capability of the method was established by enforced degradation studies combined with peak purity assessment using photodiode array detection. The degradation products formed under photolytic and oxidative conditions were investigated by electrospray ionization mass spectrometry. The method was linear over the concentration range of 50-130 µg/mL. The method was precise as demonstrated by an inter-day and intra-day relative standard deviation of less than 2.0%. The proposed validated MEKC method showed recoveries between 98.16 and 102.80% of the nominal contents. The Plackett-Burman design was applied for the robustness test in order to examine potential sources of variability by screening a large number of factors in a relatively small number of experiments.Key words capillary electrophoresis; mianserin hydrochloride; mass spectrometry Mianserin hydrochloride (Fig. 1) is a drug for the treatment of depressive illness and depression associated with anxiety. Its antidepressant effect is mainly attributed to presynaptic alfa2-adrenoreceptor blocking activity and to serotonin receptor antagonism. Mianserin is classified as an atypical antidepressant, based on its undefined action mechanism. 1)This drug is considered a weak base with two pK a values (2.7, 8.26) and chemically known as (RS)-2-methyl-1,2,3,4,10,14b-hexahydrodibenzo[c, f ] pyrazino[1,2-α] azepine hydrochloride. In humans, its major metabolic pathways include 8-hydroxylation, N-demethylation, and N-oxidation catalyzed mainly by CYP2D6, and by CYP3A4 and 1A2.2) In rats, the additional metabolite, 8-hydroxy-N-desmethylmianserin is formed from 8-hydroxyminaserin and/or N-desmethylmianserin. 3)From the analytical point of view, methods for its determination in biological fluids [4][5][6] and dosage form 7) have been reported. However, none of the reported methods for the determination of mianserin hydrochloride was shown to be a stability-indicating. It was therefore important to develop and validate a capillary electrophoresis stability-indicating method for this major compound, that can be employed in stability studies and routine quality control of its preparations. In the literature were found three relevant publications on the determination of mianserin enantiomers by capillary electrophoresis (CE). [8][9][10] The use of CE in the pharm...

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“…The in vitro cytotoxicity method was performed as described elsewhere, 19,20 based on a neutral red uptake (NRU) assay, with the exposure of NCTC clone 929 cell line (mammalian fibroblasts, ATCC number CCL-1) to the degraded samples of entecavir. The pH of the samples was adjusted to 7.0, and positive and diluent controls, together with the entecavir reference solution were included in the assay.…”

Section: In Vitro Cytotoxicity Testmentioning

confidence: 99%

Development and Validation of a Stability-indicating Capillary Zone Electrophoretic Method for the Assessment of Entecavir and Its Correlation with Liquid Chromatographic Methods

et al. 2011

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A stability-indicating capillary zone electrophoresis (CZE) method was validated for the analysis of entecavir in pharmaceutical formulations, using nimesulide as an internal standard. A fused-silica capillary (50 μm i.d.; effective length, 40 cm) was used while being maintained at 25 C; the applied voltage was 25 kV. A background electrolyte solution consisted of a 20 mM sodium tetraborate solution at pH 10. Injections were performed using a pressure mode at 50 mbar for 5 s, with detection at 216 nm. The specificity and stability-indicating capability were proven through forced degradation studies, evaluating also the in vitro cytotoxicity test of the degraded products. The method was linear over the concentration range of 1 -200 μg mL -1 (r 2 = 0.9999), and was applied for the analysis of entecavir in tablet dosage forms. The results were correlated to those of validated conventional and fast LC methods, showing non-significant differences (p > 0.05).

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Determination of rupatadine in pharmaceutical formulations by a validated stability‐indicating MEKC method

Cited by 16 publications

References 17 publications

Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

Micellar Electrokinetic Chromatographic Method for Mianserin Hydrochloride and Analysis of Degradation Products by Mass Spectrometry

Development and Validation of a Stability-indicating Capillary Zone Electrophoretic Method for the Assessment of Entecavir and Its Correlation with Liquid Chromatographic Methods

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