Development and validation of RP-HPLC method for estimation of ethacridine lactate in bulk and in pharmaceutical...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Ethacridine lactate is a pharmaceutical compound requiring accurate quantification.
• Existing analytical methods may lack simplicity, precision, or selectivity.

Purpose of the Study:

• To develop and validate a simple, precise, accurate, and selective RP-HPLC method for Ethacridine lactate estimation.
• To establish a reliable method for routine analysis in bulk drug and formulations.

Main Methods:

• RP-HPLC using a Qualisil RP C-18 column.
• Mobile phase: methanol:water (60:40 v/v) at pH 2.8.
• Detection at 271 nm with a flow rate of 1.0 mL/min.

Main Results:

• Linearity established in the range of 2-12 μg/mL (r²=0.9980).
• Quantification demonstrated good agreement with label claims.
• Validated for sensitivity, accuracy, precision, ruggedness, and robustness (LOD: 0.11 μg, LOQ: 0.33 μg).

Conclusions:

• The developed RP-HPLC method is suitable for routine analysis of Ethacridine lactate.
• The method provides accurate and precise quantification in pharmaceutical formulations.
• This technique enhances quality control in drug manufacturing.