Application of HPLC to assess the compatibility of Bisoprolol fumarate (cas 104344-23-2) with selected excipients in mixtures by isothermal stress testing

Add time:08/05/2019    Source:sciencedirect.com

SummaryIn the present study, the compatibility between Bisoprolol fumarate (cas 104344-23-2) and selected excipients (ascorbic acid, citric acid anhydrous, butylated hydroxyanisole, polyvinylpyrrolidone, glycerol, mannitol and sorbitol) in mixtures (1:10 ratio of drug and excipient) was investigated by subjecting the samples to isothermal stress conditions (90 °C for 48 h). A new HPLC method was developed, validated and employed for determining the drug content of the stressed compatibility samples. Results of HPLC revealed that major degradation of bisoprolol fumarate was observed with butylated hydroxyanisole (89.4%), citric acid anhydrous (89%), mannitol (77%) and glycerol (61.9%).

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