TRACE LEVEL DETERMINATION OF SODIUM CHLORIDE AND SODIUM SULFATE CONTENT IN SODIUM LAURETH SULFATE RAW MATERIAL USING COUNTER CATION-EXCHANGE HPLC WITH INDIRECT ULTRAVIOLET DETECTION
Objective: A novel study on a new liquid chromatographic approach has been developed and validated for simultaneous determination of trace level determination of sodium chloride and sodium sulfate measures its impurities using counter cation-exchange high-performance liquid chromatography with indirect ultraviolet (UV) detection.
Methods: Chromatographic separation is developed and validated on a Hamilton PRP-X100 column with a mobile phase contained a mixture of the para-hydroxybenzoic acid buffer with a pH of 9.0 and methanol. Chromatography is developed at a flow rate of 2.0 mL/min with an indirect UV determination at 310 nm at a sensitivity level of 0.5%. The optimized method was validated as per the ICH Q2 guidelines.
Results: The retention times of chloride and sulfate were about 2.8 and 7.6 min, respectively. The resolution between chloride and sulfate peaks is >4. Regression analysis confers a correlation coefficient for the stated compounds that are found to be >0.999.
Conclusion: A novel analytical method was validated as per the ICH method validation guidelines and found to be selective. Hence, the validated analytical method was precise, specific, and accurate, and it is more economic and simple for the determination of inorganic impurities.
2. Gajdosechova Z, Mester Z, Pagliano E. A rapid and sensitive method for the determination of inorganic chloride in oil samples. Anal Chim Acta 2019;1064:40-6.
3. Rahbar M, Paull B, Macka M. Instrument-free argentometric determination of chloride via trapezoidal distance-based microfluidic paper devices. Anal Chim Acta 2019;1063:1-8.
4. Aleksandrov PV, Medvedev AS, Imideev VA, Moskovskikh DO. Nickel sulphide concentrate processing via low-temperature calcination with sodium chloride. Part 1-identification of interaction products. Miner Eng 2019;134:37-53.
5. Dietz T, Klose J, Kohns P, Ankerhold G. Quantitative determination of chlorides by molecular laser-induced breakdown spectroscopy. Spectrochim Acta Part B At Spectrosc 2019;152:59-67.
6. Zaky AS, Pensupaa N, Andrade-Eiroae A, Tuckera GA, Dua C. A new HPLC method for simultaneously measuring chloride, sugars, organic acids and alcohols in food samples. J Food Compos Anal 2017;56:25-33.
7. Katakam LNR, Aboul-Enein HY. Elemental impurities determination by ICP-AES/ICP-MS: A review of theory, interpretation of concentration limits, analytical method development challenges and validation criterion for pharmaceutical dosage forms. Curr Pharm Anal 2019;16:392-403.
8. Kudoh M, Kusuyama T, Yamaguchi S, Fudano S. High performance liquid chromatographic determination of sodium sulfate in anionic surfactants. J Am Oil Chem Soc 1984;61:108-10.
9. Lu K. Simultaneous determination of Cl-and SO4(2-) in 30% sodium bisulfite solution samples by ion chromatography. Se Pu 2005;23:205-7.
10. Determining Chloride and Sulfate Contents in Soil, Txdot Designation: TEX-620-J; 2005. Available from: https://www.ftp.dot.state.tx.us/pub/ txdot-info/cst/TMS/600-J_series/pdfs/chm620.pdf.
11. Crafts C, Bailey B, Plante M, Acworth I. Evaluation of methods for the simultaneous analysis of cations and anions using HPLC with charged aerosol detection and a zwitterionic stationary phase. J Chromatogr Sci 2009;47:534-9.
12. Rao KLN, Reddy KP. Development and validation of a stability-indicating LC method for simultaneous determination of related compounds of guaifenesin, terbutaline sulfate and ambroxol HCl in cough syrup formulation. J Saudi Chem Soc 2014;18:593-600.
13. Rao KLN, Reddy KP. Stability-Indicating method for simultaneous determination of polar and non-polar related compounds of zidovudine in drug substance and drug product tablet form. Int J Res Pharm Sci 2015;6:5-14.
14. Dongala T, Katakam LN, Palakurthi AK, Katari NK. RP-HPLC stability indicating method development and validation of pseudoephedrine sulfate and related organic impurities in tablet dosage forms, robustness by QbD approach. Anal Chem Lett 2019;9:697-710.
15. Pathan M, Kshirsagar A. Development of validated stability indicating method by RP-HPLC for simultaneous estimation of meropenem and vaborbactam in bulk and pharmaceutical formulation. Int J Pharm Pharm Sci 2019;11:102-8.
16. Jamal MK, Gazy AA. Development and validation of analytical spectrophotometric and RP-HPLC methods for the simultaneous estimation of hydroquinone, hydrocortisone and tretinoin ternary mixture in topical formulation. Int J Pharm Pharm Sci 2019;11:10-6.
17. Rao KLN, Rao KP. Development and validation of a stability-indicating LC method for determination of bexarotene in softgel dosage formulation. Chromatographia 2017;80:1211-24.
18. Rao KLN, Reddy KP. Stability-indicating liquid chromatographic method for the simultaneous determination of ascorbic acid, citric acid, butylated hydroxyanisole. Simvastatin Relat Compounds Pharm Solid Dosage Form 2014;3:1-10.
19. Rao KLN, Reddy KP. Simultaneous estimation of fluticasone propionate, azelastine hydrochloride, phenylethyl alcohol and benzalkonium chloride by RP-HPLC method in nasal spray preparations. Int J Res Pharm Sci 2010;1:473-80.
20. IFPMA. ICH and Q2B, Harmonized Tripartite Guideline, Validation of Analytical Procedure: Methodology. Geneva, Switzerland: IFPMA, in Proceedings of the International Conference on Harmonization; 1996.
21. Pappa HN. Validation of compendial procedures. USP Pharm Forum 2019;42:8046-52.
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