Development and Validation of Stability Indicating UV SpectrophotometricMethod for the Estimation of Brimonidine Tartrate in Pure Form,Formulations and Preformulation Studies

[摘要] A new simple, sensitive and selective UV- spectrophotometric method was developed andvalidated for the estimation of brimonidine tartrate (BRT) in bulk and in formulations. Themethod was also applied for the determination of drug solubility, apparent partition coefficientand pKa. BRT was estimated at 248 nm in phosphate buffer (pH 7.4). The linearity range wasfound to be 3-18 μg/ml with a regression equation of Absorbance = 0.0630 × (concentration inμg/ml) + 0.0050. The LOD and LOQ were found to be 0.15 μg/ml and 0.45 μg/ml respectively.The method was found to be accurate (mean percentage accuracy of 99.92) and precise with %RSD less than 1.97 (for intra-day) and less than 1.36 (for inter-day). The developed method wassuccessfully employed for the determination of BRT in pharmaceutical dosage forms (ophthalmicsolutions, ocuserts and gels). Forced degradation studies with acid, alkali and temperaturebased stress conditions showed that the method is stability indicating. The determinedpreformulation parameters (solubility, apparent partition coefficient and pKa) were found to besimilar to the earlier reported results.

[学科分类] 药理学