ABSTRACT

Simple, accurate, precise, rapid and economical methods were developed for simultaneous estimation of Brimonidine tartrate and Timolol maleate in pharmaceutical dosage form. Brimonidine tartrate and Timolol maleate are used to treat glaucoma. Brimonidine is an alpha-2 adrenergic agonist. Timolol maleate is a non-selective beta-adrenergic receptor antagonist. The wavelengths maxima selected for quantification were 247.0 nm for Brimonidine tartrate and 295.0 nm for Timolol maleate. A RP-HPLC method was developed for simultaneous estimation of both drugs on ODS HYPERSIL C-18 column [250 mm,4.6 mm, 5 ?m] column using Water: Methanol: Triethylamine in the ratio of 50:50:0.2 with flow rate and detection wavelength being 1 ml/min and 266.0 nm respectively. Linearity range for Brimonidine tartrate and Timolol maleate solutions found to be 10-24 ?g/ml and 25-60 ?g/ml respectively. The retention time of brimonidine tartrate and timolol maleate was found to be 3.515 and 5.573 respectively. The column temperature was kept ambient. Linearity was observed in the concentration range of 10-24 ?g/ml (r = 0.999) and 25-60?g/ml (r = 0.999) Brimonidine tartrate and Timolol maleate respectively. Forced degradation studies were conducted according to the ICH guidelines and the drug product was found to be stable in all conditions. Hence, the method could be successfully applied for routine analysis of Brimonidine Tartrate and Timolol Maleate in combined ophthalmic dosage form. Keywords: Brimonidine tartrate, Timolol maleate, Stability, RP-HPLC, Validation
Publication date: 01/02/2023

https://ijbpas.com/pdf/2023/February/MS_IJBPAS_2023_6821.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.2.6821