Abstract

Quantitation of Metoprolol Tartrate and Propranolol Hydrochloride in Pharmaceutical Dosage Forms: Stability of Metoprolol in an Aqueous Mixture

Author(s): Gupta Vishnu D, Maswoswe J

Issue: Mar/Apr 1997 - Pediatric Care

Page(s): 125-127

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Abstract

A stability-indicating high-performance liquid chromatography assay method was developed to quantify metoprolol tartrate in pharmaceutical dosage forms. The method can also be used to quantify propranolol hydrochloride in injections and tablets. It is precise and accurate with a percent relative standard deviation of 0.9% for metoprolol and 0.7% for propranolol based on five determinations. The use of a counterion in the mobile phase is not required as described in the USPNF method. Also, the procedure for extracting the drugs from tablets is very simple and does not require mechanical shaking for 30 minutes as described in the USP-NF. The new method was used to study the stability of metoprolol in an aqueous mixture. The drug was stable for at least 10 days when stored at 25° C in amber-colored bottles. However, 10% of the drug was not available due to adsorption onto the excipient. Solutions to this problem have been recommended.

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