New RP-HPLC Method Development and Validation for Dorzolamide in Ophthalmic Dosage Form

Abstract

A reversed phase liquid chromatographic method with UV detection at 254 nm for dorzolamide assay in ophthalmic solutions was developed and validated. Chromatographic separation was achieved on a Zorbax SB C18 (250 mm × 4.6 mm, 5 µm) column kept at 30°C with an isocratic mixture of mobile phase (phosphate buffer, pH 2.5, and acetonitrile, 90 : 10 v/v) at a flow rate of 0.8 mL/min. The method was validated for its specificity, linearity, accuracy, precision, limit of detection, limit of quantification, and robustness based on ICH guidelines. The validation studies revealed satisfactory results. The proposed method has been applied for the quantification of dorzolamide in commercial samples. The developed method is fast, simple, specific, accurate, and sensitive, hence can be applied for routine quality control analysis of dorzolamide in pharmaceutical dosage form.

Quality of dorzolamide hydrochloride and timolol maleate containing eye drops distributed online

“…Several analytical methods for detecting DZA, TIM and BAC were published in scientific reports and in the pharmacopoeias (EU, British and USP). We adapted and applied, optimized and validated with the help of the tools at our disposal, rapid, simple, cost-effective and repeatable HPLC methods ( AlAani and AlNukkary, 2016 , Baker and Belal, 2018 , Erk, 2002 , ERK, 2003 , Ibrahim, 2019 , Liu et al, 2009 , Mehta et al, 2010 , Mohamed et al, 2014 , Nagori et al, 2011 , Rojsitthisak et al, 2005 , Shadoul et al, 2011 , Thangabalan et al, 2018 , Wanare et al, 2012 , Chengalva et al, 2016 ).…”

Whiter and Greener RP-HPLC Method for Simultaneous Determination of Dorzolamide, Brinzolamide, and Timolol Using Isopropanol as a Sustainable Organic Solvent in the Mobile Phase

“…The literature reports a number of RP-HPLC methods for the individual determination of dorzolamide [33,34], brinzolamide [35], and timolol [36].…”

“…Structural formula of (A) dorzolamide, (B) brinzolamide, and (C) timolol.Brinzolamide((4R)-4-(ethylamino)-2-(3-methoxypropyl)-1,1-dioxo-3,4-dihydrothieno [3,2-e] thiazine-6-sulfonamide) has the structure shown in Figure1Band is the second topical carbonic anhydrase inhibitor to receive approval from the Food and Drug Administration (FDA) for the treatment of glaucoma[30,31].Timolol((Z)-but-2-enedioicaid;(2S)-1-(tert-butylamino)-3-[(4-morpholin-4-yl-1,2,5-thiadiazol -3-yl) oxy] propan-2-ol) has the structure shown in Figure1Cand is a non-selective βadrenergic antagonist. For more than 30 years, it has been applied topically to treat glaucoma and increased intraocular pressure (IOP)[26,30,32].The literature reports a number of RP-HPLC methods for the individual determination of dorzolamide[33,34], brinzolamide[35], and timolol[36].Furthermore, the simultaneous determination of either dorzolamide with timolol[37][38][39], brinzolamide with timolol[35,40], or the determination of any of the three drugs with other related drugs[41,42] has also been reported in the literature.The above-reported methods used either acetonitrile or methanol or both together as organic constituents in the mobile phase. To our knowledge, only two HPLC methods have been published reporting the simultaneous separation and determination of the three targeted drugs; in both of them, acetonitrile[43,44], the nongreen solvent, was used in the mobile phase, no reported method used isopropanol as a mobile phase constituent.Ibrahim et al[42] developed the only reported RP-HPLC method coupled with a UV detector for the simultaneous separation and quantification of the three targeted drugs using acetonitrile as an organic constituent in the mobile phase.…”