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Stability-Indicating Rp-Hplc Method Development And Validation For Brimonidine Tartrate In Bulk And Ophthalmic Suspension.
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| Author:
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VAIJINATH G.DIGGE, S.S.PATIL, C.V.PANCHAL
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| Abstract:
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Present study involves the development of simple, accurate, rapid, sensitive and stability indicating RP_HPLC method for the determination of Brimonidine Tartrate in bulk and Brimonidine Tartrate and Brinzolamide ophthalmic suspension. In a gradient program with a flow rate of 1.2 mL/min, 1 mL orthophosphoric acid and 1 mL triflouroacetic acid in 1000 mL (Mobile Phase 1) and a mixture of acetonitrile and methanol in the ratio 40:60 v/v (Mobile Phase 2) were used. Brimonidine tartrate has a retention time of 16.907. At a wavelength of 248nm, UV detection was performed. Chromatographic separation was achieved using a 5m HPLC column made of inert sustain C18 (250*4.6). As per ICH guidelines, the method was validated using current ICH guidelines for method validation parameters such as specificity, linearity, system suitability, system precision, and method precision. Within test ranges, the Brimonidine Tartrate showed regression (R2>0.9999), and percentage recovery was found to be 99.7% in the marketed formulation. The method was found to be highly specific, with no interference from Brimonidine Tartrate impurities.
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| Keyword:
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Brimonidine Tartrate, Method Development, Forced Degaradition study, ICH guidelines, RP-HPLC.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.03.520
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| Download:
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Request For Article
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