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Quantification of potassium chloride in finished dosage forms using hilic with evaporative light scattering detector (elsd)

Author: 
Balakrishnan C., Saravanan R., Subramanian S Iyer., Gnanadev G., Rajesh Gupta and Indu Bhushan
Subject Area: 
Life Sciences
Abstract: 

A simple and efficient reverse phase high performance liquid chromatography (HPLC) method was developed for assay and dissolution of Potassium chloride in Potassium chloride extended release tablets and capsules. The analyte was detected by Evaporative light scattering detector (ELSD) at a Nitrogen gas flow rate of 1.6 mL/min. Phenomenex Luna Hydrophilic interaction liquid chromatography (HILIC) column was used to separate both potassium (cation) and chloride (anion) in a single run. The proposed method was validated as per USP and ICH recommendations for Precision, Ruggedness, Accuracy, Linearity, Specificity, Filter interference and Robustness. The linearity of the method ranged from 125 µg/mL to 1500 µg/mL, accuracy results ranged from 99.7% to 101.6% and the overall Relative Standard Deviation (RSD) for Method precision and Intermediate precision was 1.2% to 1.4%. The method can be used successfully to analyze potassium chloride drug product for its potassium chloride content.

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