✍ Scribed by Zsófia Fehér; György Horvai; Géza Nagy; Zsuzsanna Niegreisz; Klára Tóth; Ernö Pungor
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A serial analyzer with polarographic and spectrophotometric detection has been designed to speed up content uniformity tests in pharmaceutical quality control laboratories. The advantages of flow and discrete analysis are combined to provide the required speed and precision. Pharmaceutical preparations of diazepam, nitrazepam, spironolactone and pyridinolcarbamate have been tested satisfactorily. The system is easily constructed from commercially available hardware and a few home-made units. The problem of sample deaeration before polarographic measurements in flow systems is solved succesfully in a very simple way.
An important part of quality control in pharmaceutical factories is the assay of the active ingredient in each batch of tablets, capsules, etc. This is usually done by taking a representative sample of, e.g., ten tablets, homogenization and subsequent chemical analysis. In recent years, there has been a trend towards not only determining the average amount of active ingredient in each batch but also checking the uniformity of the distribution of the active ingredient within the batch. In several cases, tests for content uniformity are required by national Pharmacopoeias [ 1, 21. For such tests, at least ten individual dosage units (tablets, capsules, etc.) must be analyzed individually, usually by the same method as is used for the assay of the batch average. This, however, is not always possible because of the much smaller amount of sample (one tablet instead of ten); in some cases, a more sensitive method has to be used, e.g., differential pulse polarography instead of d.c. polarography [3]. Moreover, the introduction of content uniformity tests increases the workload of the quality control laboratory at least ten-fold. This is one reason why automation of assays for content uniformity is very desirable. The situation is actually very suitable for automation, because the samples are not only numerous but also very similar in composition.
Spectrophotometry and polarography are perhaps the most widely used instrumental analytical methods in pharmaceutical quality control, and automation of these two methods for content uniformity tests is therefore
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