Biomedical subjects

K D Altria

Publications and source records attributed to K D Altria.

At least 19 recordsLinked to original sources

PubMed1998

Optimisation, validation and application of a capillary electrophoresis method for the determination of ranitidine hydrochloride and related substances.

Ranitidine hydrochloride is an H2-antagonist which is widely prescribed for the treatment of peptic ulcers. The drug is marketed in a variety of dosage forms including tablets, syrups and injection solutions. A range of synthetic and degradative impurities of ranitidine are known and currently, these impurities are routinely determined using thin-layer chromatography (TLC). Alternatively a high-performance liquid chromatography (HPLC) method has also been employed in the assay of the pharmaceutical preparation. Unlike TLC, capillary electrophoresis (CE) offers the capability to quantify simultaneously both the active drug content and the levels of the related substances. The advantages of simplicity, selectivity, versatility and ease of use of CE offers a complementary separation technique to the established methods of HPLC and TLC in the determination of ranitidine and its related substances. This work represents a comprehensive evaluation of the performance of a developed CE method in the determination of drug-related impurities in both drug substance and various pharmaceutical formulations. The data obtained clearly shows that the performance of an optimised CE method can be equivalent in terms of sensitivity and precision to that of a HPLC method employed for a similar purpose and offers better selectivity against TLC and HPLC.

Chromatography, High Pressure Liquid↗

PubMed1997

Rapid resolution of drugs and related substances with an eCAP polyamine coated capillary.

The long term stability of a commercial polyamine coated capillary (eCAP) is described. The capillary, which can be used in the CZE and MEKC mode, is based on coating with a polyamine after conditioning with 1 M NaOH and regeneration of this coating after each run. The stability was tested over 6 months on the drug trimethoprim and the R.S.D. values for migration time and peak area were 2.86 and 3.62% respectively (n = 8, each time of determination) (> 600 sample injections over the period). This stability was utilised in the validated method developed for trimethoprim and four of its related impurities. The repeatability of peak area for trimethoprim (without normalisation or external standard) was, within-day R.S.D. = 1.02% (n = 8) and between-days R.S.D. = 2.02% (n = 8 each day). Linearity was good (for 50 micrograms ml-1 target) (y = 249.6x + 17.3 (r = 0.992, n = 6). These results for trimethoprim and for other drug mixtures were comparison with conventional capillaries and the advantage of reducing the polyamine treated eCAP capillary to a minimum length is described, to achieve rapid assay of the 5 component timethoprim mixture in < 2 min.

Acyclovir↗

PubMed1997

Validated capillary electrophoresis method for the analysis of a range of acidic drugs and excipients.

A capillary electrophoresis (CE) method employing a high pH borate buffer has been validated to allow analysis of a wide range of acidic compounds including active drugs, pharmaceutical formulations, excipients, starting materials and intermediates. An internal database has been established to demonstrate the wide applicability of the method. The method has been extensively validated and is in routine use in a number of our laboratories worldwide. In particular, acceptable injection precision is obtained through the use of internal standards and the method robustness was evaluated using an experimental design. The method allows a number of cost and time saving benefits.

Acids↗

PubMed1996

Validated capillary electrophoretic method for the quantitative analysis of histamine acid phosphate and/or benzalkonium chloride.

A novel capillary electrophoresis method has been developed and validated for the quantitative determination of histamine acid phosphate (HAP) and/or benzalkonium chloride (BKC). The solutes were separated using a pH 2.5 phosphate electrolyte with detection at 200 nm. Acceptable precision was obtained using internal standardisation. The method was also acceptable for determining levels of histidine which is an impurity in HAP. Profiling of BKC homologues was demonstrated for batch identity purposes. This method is used routinely and it is intended to register this method in the British Pharmacopoeia to supplement current test methods of TLC and HPLC.

Anti-Infective Agents, Local↗

PubMed1996

Quantitative determination of tryptophan enantiomers by capillary electrophoresis.

A novel capillary electrophoretic method is reported which allows efficient detection of 0.1% L-tryptophan in the presence of the D-enantiomer. The optimised conditions employed a triethanolamine-phosphoric acid electrolyte containing alpha-cyclodextrin. The method is also capable of acceptable injection precision resulting from the incorporation of an internal standard. The care and maintenance of the separation capillary are discussed. Acceptable validation criteria for sensitivity, precision, linearity, repeatability and recovery are included. The importance of including instrument-to-instrument method transfer in method validation is stressed and demonstrated.

Cyclodextrins↗

PubMed1996

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↗

PubMed1996