title: Application of HPLC to assess the compatibility of bisoprolol fumarate with selected excipients in mixtures by isothermal stress testing.
abstract: In the present study, the compatibility between bisoprolol fumarate 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%).
authors.affiliation: Faculty of Pharmacy, Omar Al-Mukhtar University, Tobruk, Libya. Electronic address: vkmarothu@gmail.com.
authors.forename: V K
authors.initials: VK
authors.lastname: Marothu
authors.affiliation: Alliance Institute of Advanced Pharmaceutical and Health Sciences, Hyderabad, India.
authors.forename: P
authors.initials: P
authors.lastname: Yerramothu
authors.affiliation: University College of Pharmaceutical Sciences, Acharya Nagarjuna University, Nagarjuna Nagar, India.
authors.forename: M
authors.initials: M
authors.lastname: Gorrepati
authors.affiliation: Alliance Institute of Advanced Pharmaceutical and Health Sciences, Hyderabad, India.
authors.forename: S
authors.initials: S
authors.lastname: Majeti
authors.affiliation: Alliance Institute of Advanced Pharmaceutical and Health Sciences, Hyderabad, India.
authors.forename: S K
authors.initials: SK
authors.lastname: Mamidala
authors.affiliation: Alliance Institute of Advanced Pharmaceutical and Health Sciences, Hyderabad, India.
authors.forename: A
authors.initials: A
authors.lastname: Nellutla
mesh_terms: D058671:Adrenergic beta-1 Receptor Antagonists / Q000737:chemistry*; D017298:Bisoprolol / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004344:Drug Incompatibility; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry
chemical_list: D058671:Adrenergic beta-1 Receptor Antagonists; D005079:Excipients; D017298:Bisoprolol
keywords: Bisoprolol fumarate; Compatibility; Compatibilité; Excipients; Fumarate de bisoprolol; HPLC; Mixtures; Mélanges