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Journal of Pharmaceutical and Medicinal Chemistry

Volume  10, Issue 1, Jan-June 2024, Pages 17-23
 

Review Article

Method Development and Validation for Simultaneous Estimation of Trace Level Ions in Purified Water by Ion Chromatography

Anirudh Mehta1 , Nilesh Patel K2 , Ravi Joshi M3 , Amit Vegad4 , Naicker Prashant S5

1 Graduate Student, Department of Chemical and Biochemical Engineering, Rutgers University, New Jersey, USA, 2,Associate Professor, 3,5Post Graduate Student,Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College Polytechnic Campus, Bhavnagar Road, Rajkot 360003, Gujarat, 4 General Manager, Intervein Research Lab, Ahmedabad 380015, Gujarat, India.

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DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.10124.2

Abstract

Background: A simple, accurate, precise and reproducible Ion Chromatography simultaneous estimation method development and validation for estimation of trace level ions in purified water.

Method: A specific and sensitive isocratic IC method was developed and validated for analysis of trace level ions in purified water using thermo scientific AS23 (4×250 mm) with flow rate 1.0 ml/min and Temperature 30 °C. The isocratic mode was used for elution and the mobile phase was 30 mM KOH.

Result: The samples were analyzed using 70 µl injection volume. The developed method was validated as per ICH Q2R1 for linearity, specificity, accuracy, precision, limit of detection, limit of quantification and robustness. The linearity of the proposed method was investigated in the range of 0.1-2.0 ppm for Fluoride, Chloride, Nitrite, Bromide, Nitrate, and Sulfate (R2 = 0.9991,0.9974,0.9997,0.9982,0.9979,0.9968). The % accuracy was found to be in the range of Fluoride, Chloride, Nitrite, Bromide, Nitrate and Sulfate was found to be in range of 98.05 –99.79%, 98.17 – 101.04%, 99.62 – 101.06%, 98.96 – 102.04%, 99.80 – 101.04%, 99.59 – 102.31%. The RSD for precision and robustness was found less than 2.

Conclusion: A rapid and sensitive isocratic elution mode analytical method was developed and validated for the simultaneous analysis for Purified water. Fluoride, Chloride, Nitrite,Bromide, Nitrate and Sulfate been validated in accordance with ICH Q2 (R1) requirements.


Keywords : Purified water; Analytical Method validation; Trace level Anions; Ion Chromatography.
Corresponding Author : Anirudh Mehta,