Validation of a sensitive ion chromatography method for determination of monoethylsulfate in Indinavir sulfate drug substance

A simple, sensitive, specific, linear and effective Ion chromatography method has been developed and validated for the determination of Isopropylamine content in Metoprolol Succinate. Isopropylamine is possible impurity that may be present in Metoprolol succinate samples. The method was validated as per International Council for Harmonisation (ICH) guidelines, for which limit of detection and limit of quantitation obtained were 29 ppm and 87 ppm respectively. % RSD for System precision observed was 1.38. The regression coefficient found for the linearity study was 0.9997. The % recovery of the spiked Isopropylamine in drug substance obtained was in the range of 83.2 to 100.7 from 50 % to 150 % level ensured the accuracy of the method. The method can be adapted to determine Isopropylamine content in Metoprolol Succinate drug substance (API). Keywords: Ion chromatography (IC), Metoprolol Succinate, Isopropylamine, development, validation.

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Ion chromatography method and validation for the determination of sulfate and sulfamate ions in topiramate drug substance and finished product

Journal of Chromatography B Biomedical Sciences and Applications ◽

10.1016/s0378-4347(98)00048-6 ◽

1998 ◽

Vol 709 (1) ◽

pp. 166-172 ◽

Cited By ~ 17

Author(s):

Arthur P Micheel ◽

Chan Y Ko ◽

H.Y Guh

Keyword(s):

Ion Chromatography ◽

Drug Substance ◽

Chromatography Method

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Stationary source emissions. Determination of mass concentration of sulfur dioxide. Ion chromatography method

10.3403/01331011 ◽

1998 ◽

Keyword(s):

Sulfur Dioxide ◽

Ion Chromatography ◽

Mass Concentration ◽

Chromatography Method ◽

Stationary Source

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Determination of Cl- in Concrete Materials by Ion Chromatography

Key Engineering Materials ◽

10.4028/www.scientific.net/kem.680.52 ◽

2016 ◽

Vol 680 ◽

pp. 52-55

Author(s):

Hong Yan Guan ◽

Jian Jun Ding ◽

Zhong Bao Guo ◽

Ming Yu Wang ◽

Yi Fei Mei

Keyword(s):

Detection Limit ◽

Ion Chromatography ◽

Potential Method ◽

Concrete Cover ◽

Chloride Ions ◽

Accurate Analysis ◽

Chromatography Method ◽

Concrete Materials ◽

Corrosion Of Steel

The determination of chloride ions in concrete materials accurately is far and away crucial, since chloride ions can cause corrosion of steel and concrete cover off. The conventional potential method and silver nitrate titration method usually show features of simple operation and short duration, nevertheless, they are not suitable for accurate analysis for concrete attributing to their low accuracy and detection limit. In this paper, an ion chromatography method was presented to determine chlorine in concrete materials. Concrete samples were pre-processed and then extracted with distilled water. The extraction solutions were purified on a 0.22 μm filter membrane, an On Guard SPE-RP column and a SPE-H column sequentially for eliminating undissolved substance, organisms and metal ions before ion chromatographic analysis. The chromatographic separation was performed on a Dionex ICS-1000 Chromatographic using 25.0 mmol/L KOH solutions as mobile phase at 1.0 mL/min. Results show that the detection limit of the method was 0.004 mg/L. The linear relationship of the external Cl- standard solutions was 0.9994, and the sample analytical RSD was 0.44%.

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