Abstract

Analytical Method Development for Dorzolamide Using UV Spectroscopy

Author(s): Sachin Kothawade*, Shubhangi Albhar, Vijaykumar Wakale, Sandesh Bole, Kunal Raut, Prashant Patil, Jay prakash Suryawanshi, Payal Navasupe, Rachana Hajare, Sharmila Kuskar, Vaibhav Wagh and Vishal Pande

The development and evaluation of an analytical technique for the UV spectroscopy based determination of Dorzolamide is the main focus of this study. Dorzolamide, a carbonic anhydrase inhibitor, is utilized to reduce intraocular pressure in the treatment of ocular hypertension and openangle glaucoma. The study involved establishing the maximum wavelength (λ_max) of Dorzolamide HCL as 253 nm, confirmed by UV spectra in different media. The method's validation included linearity testing, where a calibration curve exhibited a strong correlation (R²=0.9995) in simulated tear fluid. Accuracy studies demonstrated a high precision of 98%-100%, while precision tests, both intra-day and inter-day, indicated a %RSD of less than 2%, confirming the method's reliability. The method's sensitivity was assessed with Limit of Detection (LOD) and Quantification (LOQ) found as 0.37 μg/ml and 1.12 μg/ml, respectively. Robustness and ruggedness assessments further supported the method's reliability, with %RSD values within acceptable ranges. The developed UV spectroscopy method for Dorzolamide analysis exhibits excellent accuracy, precision, sensitivity and robustness, making it a valuable tool for pharmaceutical quality control.

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