International Journal of Pharmaceutical Compounding

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Extemporaneous Formulations: How to Evaluate HPLC Stability Studies

Author(s): Chan Debora Schotik

Issue: Nov/Dec 1999 - Compounding for Arthritis Patients
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Page(s): 447-451

Extemporaneous Formulations: How to Evaluate HPLC Stability Studies Page 1

Extemporaneous Formulations: How to Evaluate HPLC Stability Studies Page 2

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Abstract: This article begins with a scenario suggested by the author: if a physician consults a pharmacist to provide a beyond-use date for an extemporaneously compounded medication, what should he or she do? She then discusses the search for a beyond-use date, quality measures (accuracy, precision, sensitivity and specificity, study-drug sample-solution analyses and internal standard) and using the worksheets. The worksheets alluded to are also provided (a High-Performance Liquid Chromatography Methodology Worksheet, Methodology Worksheet Results Worksheet and Formulation Batch Sheet). A glossary of terms accompanies the article.

Related Keywords: HPLC, stability studies, chromatography, accuracy, precision, specificity, sensitivity, internal standard

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