Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2011 Vol: 3 Issue: 4

Method Development and Its Validation for Simultaneous Estimation of Timolol Maleate and Dorzolamide Hydrochloride in as API and In Ophthalmic Solution Dosage Form by RPHPLC

Abstract

Dorzolamide Hydrochloride is used to lower the increased intraocular pressure in open-angle glaucoma and ocular hypertension. Timolol maleate is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. In this article, a high performance liquid chromatography (HPLC) method with UV-Visible detector wavelength (254 nm & 295 nm) for Dorzolamide Hydrochloride & Timolol maleate was developed and validated. The mobile phase consisted of methanol : buffer (60:40), the pH was adjusted to 3 with glacial acetic acid, was run through a Column C-18, (EC 150/4.6 NUCLEOSIL 100-5), reverse phase analytical column. The experiment was carried out at room temperature for Dorzolamide Hydrochloride & Timolol maleate. Analytical run time was less than 10 min. The assay exhibited good linear relationship. Accuracy & Precision were over the concentration range of 10 to 30 mg/ml & 40 to 120 mg/ml for Dorzolamide Hydrochloride and Timolol Maleate respectively. This method was found to be applicable for determination of the Dorzolamide Hydrochloride & Timolol maleate in active pharmaceutical ingredient (API) and pharmaceutical product also.

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