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Miscellaneous (32)

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Abstract #46779 Published in IGR 13-3

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

Nagori BP; Maru A; Muysuni P; Gupta S
Journal of Chemical and Pharmaceutical Research 2011; 3: 866-874

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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 (mu)g/ml & 40 to 120 (mu)g/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.

A. Maru. Brawn Laboratories Ltd, New Delhi, India.

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Classification:

11.3.4 Betablocker (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
11.5.2 Topical (Part of: 11 Medical treatment > 11.5 Carbonic anhydrase inhibitors)

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