Validation of a Reverse-Phase HPLC Assay for Tetracycline Hydrochloride in CT Albaplex and CT Delta-Albaplex
Stratton, Jamie L.
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The function of a pharmaceutical quality control division is to provide assurance that each lot of every product distributed meets the standards set forth by the company and regulatory agencies. Two of these standards are potency and content uniformity. For each lot of each product, a sample must be tested to be certain that the potency falls within a given range of percent of label. For example, if a product label indicates that each tablet contains 100 mg of active ingredient, then a test for potency (called a potency assay) should yield a result generally between 97 and 103 mg/tablet. It is also very common to do a content uniformity assay, in which ten tablets are chosen at random and assayed, to be certain that the potency is fairly consistent within a lot. Particularly where antibiotics and biological compounds are concerned, a very common assay method is the use of high-performance liquid chromatography (HPLC). The goal of this project was to validate a reverse-phase HPLC assay for the determination of tetracycline hydrochloride in two Upjohn veterinary products, CT Albaplex and CT Delta-Albaplex, in both the IX and the 3X strengths, which would be useful for both potency and content uniformity studies. The results of this validation attempt were excellent. The proposed HPLC assay shows no drug peak interferences, exhibits linearity in both detection of bulk drug and recovery of drug from placebo, and is clearly better in terms of accuracy and precision than the current microbiological method.