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K D Altria

Publications and source records attributed to K D Altria.

At least 37 records · Page 2Linked to original sources

Determination of drug-related impurities by capillary electrophoresis.

The use of capillary electrophoresis (CE) to determine drug-related impurities is becoming established within industrial pharmaceutical analysis laboratories. Increasingly CE is being viewed as an alternative for, and complement to, high-performance liquid chromatography (HPLC). This paper comprehensively reviews the progress of CE in drug impurity determinations subdividing the reports into low pH, high pH and MECC applications. The section covering method performance and validation clearly shows that CE methods are capable of validation in this area and can often give equivalent performance to HPLC methods. Possible benefits of adopting CE for this testing include reductions in costs and improved robustness. Potential developments are covered including the use of electrolyte additives, instrumental developments and the increased implementation of electrochromatography. It is concluded that the current status of CE is sufficiently strong to allow the analyst to view CE as a viable and attractive alternative to HPLC.

Chemistry, Pharmaceutical↗

Troubleshooting.

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Automation↗

Method validation.

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Adrenergic alpha-Antagonists↗

Application of chemometric experimental designs in capillary electrophoresis: a review.

Various chemometric experimental designs have been employed for the optimisation of capillary electrophoresis (CE) methods. Similar designs have been utilised in the assessment of the robustness of CE methods. The designs employed include central composites, fractional factorials, Plackett-Burman, simplex and overlapping-resolution mapping. Optimisation studies have largely concentrated on the use of these designs on selection of the optimal electrolyte composition. The robustness testing studies performed have involved the use of screening designs to identify the critical parameters affecting responses such as migration times and resolution. Further designs such as central composites have then been employed to set method limits following robustness studies. It is concluded that the use of experimental designs and statistical data evaluation in conjunction with personal computer-controlled CE autosamplers and instruments are of great benefit in the optimisation and robustness evaluation of CE methods.

Electrophoresis, Capillary↗

Validation of a capillary electrophoresis method for the determination of potassium counter-ion levels in an acidic drug salt.

This paper describes the first report of the validation of a capillary electrophoresis method for the quantitative determination of potassium levels in the potassium salt of an acidic drug. Validation criteria include precision, linearity, robustness and repeatability. The use of an internal standard enabled precision values of < 1% RSD to be obtained for peak area ratios. Careful control of capillary conditioning and temperature enabled migration time precisions of < 0.5% RSD. Results obtained by this method were in agreement with those generated by ion exchange chromatography and the theoretical potassium content of samples tested. Features of the method, compared to alternative analytical techniques, include simplicity, speed and accuracy. The method is now in routine use within our laboratories.

Calibration↗

Validated capillary electrophoresis method for the assay of a range of basic drugs.

A capillary electrophoresis method has been developed and validated for the analysis of a wide range of basic drugs. Acceptable precision was obtained by employing an internal standard. Optimal sensitivity was obtained using low UV wavelengths. An experimentally designed study showed the method to be robust. The method has advantages over HPLC in terms of simplicity, speed and cost. The method is now in routine use for identity confirmation and assay of both drug substance and formulations.

Buffers↗