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Abstract <p>A sensitive and simultaneous RP-HPLC strategy has been developed for analysing timolol maleate and dorzolamide hydrochloride along with their related substances. To achieve separation of both these drugs and their impurities Inertsil ODS 3&#xa0;V, 250&#xa0;mm × 4.6&#xa0;mm, 5&#xa0;μm column, with a gradient mobile phase comprising of sodium dihydrogen phosphate buffer pH 3.5 along with 0.05% v/v Orthophosphoric acid solution in acetonitrile has been employed. The flow rate was maintained as 1.0 mL/min by selecting the detection wavelength at 254&#xa0;nm for dorzolamide and 295&#xa0;nm for timolol. The developed technique was verified with compliance to ICH requirements for various parameters, including linearity, precision, robustness, specificity, and accuracy. The mean recovery rates for dorzolamide hydrochloride, timolol maleate and their impurities varied from 90%–110%. With a separation time of 55&#xa0;min, the medications dorzolamide hydrochloride and timolol maleate show linear relation with a correlation coefficient greater than 0.99 within the concentration range of 1.0&#xa0;µg/mL to 30.3&#xa0;µg/mL for dorzolamide and 0.6&#xa0;µg/mL to 3.9&#xa0;µg/mL for timolol respectively. This analytical technique will be highly useful for quantification of known and unknown impurities in drug product formulation from QC and DRA submission point of view.</p> Graphical Abstract <p></p>

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A novel stability indicating RP-HPLC method of related substances for dorzolamide hydrochloride and timolol maleate in glaucoma treatment ophthalmic formulation

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  • 发表日期：

    2025年11月19日

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  • Harmeet Kaur Kohli,
  • Satish K. Ghumare,
  • Vijay A. Bagul

摘要

Abstract

A sensitive and simultaneous RP-HPLC strategy has been developed for analysing timolol maleate and dorzolamide hydrochloride along with their related substances. To achieve separation of both these drugs and their impurities Inertsil ODS 3 V, 250 mm × 4.6 mm, 5 μm column, with a gradient mobile phase comprising of sodium dihydrogen phosphate buffer pH 3.5 along with 0.05% v/v Orthophosphoric acid solution in acetonitrile has been employed. The flow rate was maintained as 1.0 mL/min by selecting the detection wavelength at 254 nm for dorzolamide and 295 nm for timolol. The developed technique was verified with compliance to ICH requirements for various parameters, including linearity, precision, robustness, specificity, and accuracy. The mean recovery rates for dorzolamide hydrochloride, timolol maleate and their impurities varied from 90%–110%. With a separation time of 55 min, the medications dorzolamide hydrochloride and timolol maleate show linear relation with a correlation coefficient greater than 0.99 within the concentration range of 1.0 µg/mL to 30.3 µg/mL for dorzolamide and 0.6 µg/mL to 3.9 µg/mL for timolol respectively. This analytical technique will be highly useful for quantification of known and unknown impurities in drug product formulation from QC and DRA submission point of view.

Graphical Abstract