Development and validation of RP-HPLC Method for the Simultaneous Estimation of Brimonidinetartrate and Timolol maleate in Combined Dosage form

Author Details
Nagaraju P*, Kiran Kumar S, Poornima Ch
Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur-522002, (A.P.) India.

Abstract
A simple, efficient, and reproducible RP-HPLC method for the simultaneous determination of Brimonidine tartrate and Timolol maleate in bulk and in pharmaceutical formulations has been developed and validated. The chromatographic analysis was performed on a Inertsil ODS hypersilC₁₈ (150 x 4.6 mm i.d, 5µ) column in isocratic mode usingAcetonitrie:0.02 M 1-octane sulfonic acid buffer (adjusted to pH 3.35 with ortho-phosphoric acid) in the ratio of 50:50v/v as eluent. The flow rate was 1 ml/min and eluent was detected at 285 nm. The retention time of Brimonidine tartrate and Timolol maleatewere 3.017 and 5.943 min, respectively. The linear dynamic range was 2-12 µg/ml and 5-30 µg/ml for Brimonidine tartrate and Timolol maleate, respectively. Percentage recoveries for Brimonidine tartrate and Timolol maleate were 100.05 and 100.48 %, respectively. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method is also found to be precise and robust for the simultaneous determination of Brimonidine tartrate and Timololmaleatein tablet dosage forms.
Keywords: Brimonidine tartrate, Timololmaleate and Simultaneous determination