Abstract
This manuscript details the modifications made to the HPLC assay method described in the USP monograph for Acetazolamide Compounded Oral Suspension.•The method was modified to allow the quantification of acetazolamide in two new suspension vehicles: Oral Mix and Oral Mix SF;•It was validated for linearity, accuracy, precision and specificity;•It was demonstrated stability-indicating and suitable for use in a stability study using these vehicles.
Highlights
When a liquid oral dosage form is required, it can be prepared extemporaneously according to the USP monograph for Acetazolamide Compounded Oral Suspension [6]
New liquid oral acetazolamide formulations were developed using Oral Mix and Oral Mix SF suspension vehicles and a stabilityindicating method was required in order to conduct a stability study for these new formulations
This manuscript details the modifications made to the USP methods for the quantification of acetazolamide in Oral Mix and Oral Mix SF vehicles
Summary
Platform of Biopharmacy, Faculty of Pharmacy, Université de Montréal, Montréal, Canada abstract This manuscript details the modifications made to the HPLC assay method described in the USP monograph for Acetazolamide Compounded Oral Suspension. The method was modified to allow the quantification of acetazolamide in two new suspension vehicles: Oral Mix and Oral Mix SF;. It was validated for linearity, accuracy, precision and specificity; It was demonstrated stability-indicating and suitable for use in a stability study using these vehicles. Subject Area: More specific subject area: Method name: Name and reference of original method: Resource availability: Pharmacology, Toxicology and Pharmaceutical Science. Oral suspensions, compounding, extemporaneous preparations, stability studies Stability-indicating HPLC-UV method for acetazolamide in Oral-Mix and Oral-Mix SF United States Pharmacopeia 42 — National Formulary 37: Acetazolamide Oral.
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