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RP-HPLC method development and validation for the estimation of Acetazolamide in bulk drug and formulations with forced degradation studies | Abstract
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Abstract

RP-HPLC method development and validation for the estimation of Acetazolamide in bulk drug and formulations with forced degradation studies

Author(s): Satish Manchanda, Pravat K. Sahoo and Dipak K. Majumdar

This work has been done with a motto to develop a simple, accurate, precise, reproducible and economic reverse phase HPLC method for Acetazolamide in bulk drug as well as in formulations. in the current developed method C8H column (250x4.6mm) was used as stationary phase and potassium dihydrogen phosphate buffer (pH 3), Acetonitrile & water in a ratio 30:20:50 as mobile phase. ICH guidelines were followed for method validation and different parameters studied include linearity range, system suitability, specificity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), Robustness and Solution Stability. Forced degradation studies were also done by exposing the drug to different stress conditions (Photolytic, thermal, acidic, alkaline, & Oxidative). The developed validated method was also utilized to quantify the Acetazolamide in the marketed formulation successfully. The method was found linear within the range of 20-120μg/mL with LOD of 37.60ng/mL & LOQ of 0.11396μg/mL whereas recovery was found within the range of 99.98% -100.77%. Method was found to be able to distinguish the parent drug from degraded products & quantify Acetazolamide in Dosage form (101.14%). A linear, robust & economic RP-HPLC method was developed with LOD & LOQ within the good range which can be adopted for the routine analysis of Acetazolamide in bulk drugs & formulations.


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