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APPLICATION OF ION PAIR RP–HPLC METHOD IN PHARMACEUTICAL QUALITY CONTROL DISSOLUTION TESTING FOR SIMULTANEOUS ESTIMATION OF COMBINED TABLET DOSAGE FORMS WITH ACETYLSALICYLIC ACID AND GLYCINE

100%
Kowalska M. K., Wozniak M., Kijek M., Krawczyk M., Janas S.
Acta Poloniae Pharmaceutica - Drug Research
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2018
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vol. 75
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issue 3
EN
The aim of the paper was to present the possibility of applying the novel method (RP-HPLC ion pair method) for the simultaneous dissolution determination of combined tablet dosage form containing acetylsalicylic acid and glycine in pharmaceutical industry. The samples were gradient eluted using a Pursuit XS Ultra C18 column (150x3.0 mm, with a particle size of 2.8µm) with variable composition of mobile phase A (1-heptanesulfonic acid sodium salt aqueous solution (2.8 g/L), pH 2.2 ± 0.05 adjusted with orthophosphoric acid) and phase B (methanol). The detection was carried out at 210 nm with a consist flow rate of 0.4 mL min−1. The method was validated by determining precision (repeatability and intermediate precision), accuracy, specificity, linearity, range, system suitability, robustness and stability in accordance with ICH guidelines. The method was accurate, precise and linear within the range of 0.03 – 0.18 mg mL−1 for acetylsalicylic acid and 0.016 – 0.096 mg mL−1 for glycine. The method is simple, convenient and suitable for analyzing acetylsalicylic acid and glycine in pharmaceutical formulations. The method could also be used for routine assay determination after small modification of sample preparation.
2
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PURITY DETERMINATION OF THE STARTING MATERIALS USED IN THE SYNTHESIS OF PHARMACEUTICAL SUBSTANCES

100%
Groman A., Stolarczyk E., Mucha M.
Acta Poloniae Pharmaceutica - Drug Research
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2019
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vol. 76
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issue 1
29-35
EN
High requirements on the API quality mean that the quality control of the starting material is crucial to the manufacturing process of drug substances. Three sensitive methods for the purity determination of the following starting materials: ethylene glycol (method I), 3-acetylpyridine (method II) and 4-chloromethyl-5-methyl-1,3-dioxol-2-one (method III) used in the synthesis of selected drug substances were developed using GC-FID techniques. All the methods were validated according to the International Conference on Harmonization guidelines. The correlation coefficient values were found about 0.99. The obtained RSD values from the replicate injections in the range of 20 - 120% of the nominal concentration ensured the precision.
3
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Method validation in quantitative electrochemical analysis of colchicine using glassy carbon electrode

100%
Bodoki E., Săndulescu R., Roman L.
Open Chemistry
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2007
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vol. 5
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issue 3
766-778
EN
A cathodic differential pulse voltammetric determination of colchicine was validated using a glassy carbon electrode in HClO4/H3PO4 0.01 M. Colchicine gives an irreversible, diffusion-controlled peak at −862 mV vs. Ag/AgCl reference electrode. The cathodic peak is strongly influenced by a more alkaline environment with a shift towards more negative potentials. Method optimization was carried out in parallel for three types of electrodes (glassy carbon, mercury film and bismuth film coated glassy carbon). The cathodic peak current is higher using film-coated electrodes, but shows poorer intra-day reproducibility and a longer analysis time due to film renewal. Thus, a bare glassy carbon electrode was used to determine colchicine in the concentration range of 2.4 − 50 μg mL−1 (R 2 = 0.9998, n = 5), with a calculated detection limit of 0.80 μg mL−1. The proposed method was characterized according to ICH Harmonized Tripartite Guidance Q2(R1) by validation parameters (selectivity, linearity, accuracy, fidelity, limit of detection, limit of quantification) and it was successfully applied for the determination of colchicine from tablets, without the interference of the excipients. The method’s performances were evaluated and compared with both a known polarographic method and the official quantitative spectrophotometric determination from the Romanian Pharmacopoeia, Xth edition, respectively. [...]
4
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METHOD VALIDATION AND STABILITY STUDIES OF DIFFERENTIAL ACTIVITY OF HYDROXYPROPYL-β-CYCLODEXTRIN AND HYDROPHILIC CARRIERS OF CARVEDILOL.

86%
Boakye-Yiadom K. O., Kesse S., Korto K., Sarkodie E. K., Baidoo S. A., Filli M. S., Wang B.
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EN
Stability studies of the formulations of CAR solid dispersions were analyzed at 300C/65%RH for a period of three months. A simple reverse phase HPLC was developed and validated for the quantification of CAR solid dispersions. Chromatographic separation was achieved on Waters Atlantis dC18 (4.6 X 150mm) column with a mobile phase consisting of 0.033M phosphate buffer and methanol (35:65). The mobile phase was filtered using an organic filter paper and sonicated for about 20 min. The flow rate was 1ml/min and 242nm wavelength was used for detection. Force degradation studies were conducted under three conditions namely; acidic, basic and hydroxide peroxide conditions. With the HPLC linearity concentration was in the range of 5-80μg/ml with a correlation coefficient (R2) of 0.9995. There was no interference with drug carriers. The suggested reverse phase HPLC methodology is simple, selective, linear and robust in quantifying the amount of CAR in the various solid dispersion samples. In hydrogen peroxide a degraded product was found on the chromatogram unlike that of the acidic and basic conditions. Degradation occurred more strongly in the acidic condition than in the basic condition. The binary systems were less stable than the ternary system solid dispersions due to the presence of HP-β-CD.
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