Reversed Phase Liquid Chromatographic Method for the High‐Throughput Analysis of Clopidogrel in Pharmaceutical Formulations Using a Monolithic Silica Column

Aboul‐Enein, Hassan Y.; Hoenen, Hubert; Ghanem, Ashraf; Koll, Michael

doi:10.1081/jlc-200054835

Cited by 15 publications

(6 citation statements)

References 9 publications

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“…Clopidogrel (CL) has been determined in pharmaceutical preparations by spectrophotometric [5,6] and LC [7,8] methods. A stability-indicating method was developed for its determination in the presence of its degradation products under stressed conditions using TLC [9].…”

Section: Introductionmentioning

confidence: 99%

Separation and determination of clopidogrel and its impurities by capillary electrophoresis

Fayed

Weshahy

Shehata

et al. 2009

Journal of Pharmaceutical and Biomedical Analysis

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Section: Introductionmentioning

confidence: 99%

Separation and determination of clopidogrel and its impurities by capillary electrophoresis

Fayed

Weshahy

Shehata

et al. 2009

Journal of Pharmaceutical and Biomedical Analysis

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“…[5][6][7] Thin layer chromatography (TLC) has been used to perform stabilityindicating method 8 and impurity assay of S-acid in clopidogrel dosage forms. 9 A limited number of publications refer to enantiospecific determination of clopidogrel.…”

Section: Introductionmentioning

confidence: 99%

A validated enantiospecific method for determination and purity assay of clopridogrel

et al. 2008

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A new and accurate HPLC method using beta-cyclodextrin chemically bonded to spherical silica particles as chiral stationary phase (CSP) was developed and validated for determination of S-clopidogrel and its impurities R-enantiomer and S-acid as a hydrolytic product. The effects of acetonitrile and methanol content in the mobile phase and temperature on the resolution and retention of enantiomers were investigated. A satisfactory resolution of S-clopidogrel active form and its impurities was achieved on ChiraDex column (5 microm, 4 x 250 mm) at a flow rate of 1.0 ml/min and 17 degrees C using acetonitrile, methanol and 0.01 M potassium dihydrogen phosphate solution (15:5:80 v/v/v) as mobile phase. The detection wavelength was set at 220 nm. The method was validated in terms of accuracy, precision, linearity, and robustness. The limit of detection for R-enantiomer and S-acid were 0.75 and 0.09 microg/ml, respectively, injection volume being 20 microl. Finally, the molecular modeling of the inclusion complexes between the analytes and beta-cyclodextrin was performed to investigate the mechanism of the enantiorecognition and to study the quantitative structure-retention relationships.

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“…Each 1 mL contains 15 mg of Nizatidine along with inactive ingredients methylparaben, propylparaben, glycerin, sodium alginate, purified water, sodium chloride, saccharin sodium, sodium citrate dihydrate, citric acid anhydrous, sucrose, bubble gum flavor, artificial sweetness enhancer, and sodium hydroxide. [1] Literature survey reveals few analytical methods reported for quantification of Nizatidine by LC, [2][3][4][5][6][7] by capillary electrophoresis (CZE), [8] by thin-layer chromatography (TLC), [9] and by titrimetric [10] methods.…”

Section: Introductionmentioning

confidence: 99%

Stability-Indicating Lc Method for the Estimation of Nizatidine Impurities in Nizatidine Oral Solution

Rao

Kumar

Prasad

et al. 2014

Journal of Liquid Chromatography & Related Technologies

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& A novel stability-indicating reversed phase liquid chromatographic (RP-LC) method was developed for the determination of purity of Nizatidine in Nizatidine oral solutions in the presence of its impurities and degradation products. Two unknown impurities were formed in the formulated drug under the stress conditions (40 C=75% RH for 3 months), with relative retention times (RRTs) 0.93 and 2.14. The two degradant impurities were isolated and characterized using liquid chromatography mass spectrometry (LC-MS). Chromatographic method was developed and validated for Nizatidine United States Pharmacopeia (USP) impurities along with the two degradant impurities. Total 13 impurities were well separated and not interfering with placebo peaks in oral solution. The method was developed using C-18 column in gradient elution mode. The eluted compounds were monitored at 254 nm. Nizatidine was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness, and ruggedness.

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Reversed Phase Liquid Chromatographic Method for the High‐Throughput Analysis of Clopidogrel in Pharmaceutical Formulations Using a Monolithic Silica Column

Cited by 15 publications

References 9 publications

Separation and determination of clopidogrel and its impurities by capillary electrophoresis

Separation and determination of clopidogrel and its impurities by capillary electrophoresis

A validated enantiospecific method for determination and purity assay of clopridogrel

Stability-Indicating Lc Method for the Estimation of Nizatidine Impurities in Nizatidine Oral Solution

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