A stability-indicating RP-HPLC method for the simultaneous quantification of brimonidine tartrate and timolol maleate in bulk drug substances and pharmaceutical dosage forms.

ABSTRACT: A robust, rapid, and reproducible reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous quantification of Brimonidine Tartrate and Timolol Maleate (Combigan) in ophthalmic dosage forms. Chromatographic separation was achieved on a Supelco Discovery C18 column (25 cm × 4.6 mm, 5 μm) maintained at ambient temperature, employing isocratic elution with two mobile phases: phase A (buffer at pH 7.0 containing 30 mM triethylamine) and phase B (acetonitrile) in a ratio of 80:20. The flow rate was set at 1.0 mL/min, and detection was performed at 245 nm and 295 nm using a diode array detector (DAD). Method validation, conducted in accordance with ICH Q2(R1), USP, and FDA guidelines, confirmed excellent linearity over the ranges of 0.

SUBMITTER: Mestareehi A 

PROVIDER: S-EPMC12852716 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature