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

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

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Journal of Pharmaceutical and Medicinal Chemistry 10(1):p 17-23, Jan-June 2024. | DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.10124.2

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Anirudh Mehta, Nilesh Patel K., Ravi Joshi et al. Method Development and Validation for Simultaneous Estimation of Trace Level Ions in Purified Water by Ion Chromatography. J Pharmaceut Med Chem. 2024;10(1): 17-23.

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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.

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Anirudh Mehta, Nilesh Patel K., Ravi Joshi et al. Method Development and Validation for Simultaneous Estimation of Trace Level Ions in Purified Water by Ion Chromatography. J Pharmaceut Med Chem. 2024;10(1): 17-23.

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

Keywords

Purified water; Analytical Method validation; Trace level Anions; Ion Chromatography.

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