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Validated Chromatographic Methods for the Determination of Process Related Toxic Impurities in Pantoprazole Sodium

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Abstract

A GC–MS method for the simultaneous determination of two process related toxic impurities viz. 2-(chloromethyl)-3,4-dimethoxypyridine hydrochloride (CDP) and dimethyl sulfate (DMS) and RP-LC for the routine determination of CDP in pantoprazole sodium (PPS) are presented. In GC–MS, a temperature gradient program was performed on a capillary DB-624 column (60 m × 0.32 mm × 1.8 μm). LC analysis of CDP was done on a Novaflex C18 (250 × 4.6 mm, 5 μm) column using mobile phase containing buffer (0.02 M potassium dihydrogen phosphate and 0.0025 M di potassium hydrogen phosphate) and acetonitrile in 46:54 v/v ratio. The flow rate was 1.0 mL min−1 and the elution was monitored at 220 nm. Both methods were validated as per International Conference on Harmonization (ICH) guidelines. GC–MS is able to quantitate up to 3.0 ppm of CDP and DMS whereas with RP-LC up to 9.0 ppm of CDP could be quantitated.

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Acknowledgments

The authors are highly thankful to Dr. Bandi Parthasarathi Reddy, CMD, Hetero Drugs Limited, Hyderabad, India for his encouragement and providing facilities to carry out this research work.

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Authors and Affiliations

  1. Hetero Drugs Ltd. (R & D), Plot No. B. 80 and 81, APIE, Balanagar, Hyderabad, 500018, India

    Nanduri V. V. S. S. Raman, Kura Ratnakar Reddy & Adapa V. S. S. Prasad

  2. College of Science, GITAM University, Visakhapatnam, 530045, India

    Karipeddi Ramakrishna

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  1. Nanduri V. V. S. S. Raman
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  2. Kura Ratnakar Reddy
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  3. Adapa V. S. S. Prasad
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  4. Karipeddi Ramakrishna
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Correspondence to Karipeddi Ramakrishna.

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Raman, N.V.V.S.S., Reddy, K.R., Prasad, A.V.S.S. et al. Validated Chromatographic Methods for the Determination of Process Related Toxic Impurities in Pantoprazole Sodium. Chroma 68, 481–484 (2008). https://doi.org/10.1365/s10337-008-0718-z

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  • DOI: https://doi.org/10.1365/s10337-008-0718-z

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