International Journal For Multidisciplinary Research

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Hyphenated Technique Used for the Analysis of Pharmaceutical Impurities: A Comprehensive Review

Author(s) Ms. Amisha Bharti, Mr Vinod Kumar Gurjar
Country India
Abstract The term "Hyphenated Technique" describes a set of analytical techniques that improve pharmaceutical impurity identification and characterization. This comprehensive review uses several hyphenated techniques; The review of hyphenated techniques includes various techniques which are used nowadays for analysis. One of the powerful tools of impurity profile is like Chromatographic techniques like GC, LC etc., which are used for the separation and spectroscopic techniques such as NMR, MS, and IR used for the identification of impurities in pharmaceutical analysis are covered in this thorough overview found as necessary steps to measure for this compounds at extremely low concentrations. Such methods can increase sensitivity, specificity, and resolution, so that patterns of sophisticated impurities in drug substances can be indeed detected. The review would also include issues like regulation as well as challenges in the development of new methods and importance of precise impurity profiling with respect to safety and efficacy in pharmaceuticals. It certainly demonstrates a distinct hyphenated approaches towards modem pharmaceutical quality control and regulatory compliance. Thus, it is in the light of this review that the significance of hyphenated techniques in ensuring drug safety, efficacy and compliance comes out through the current innovations. Nanogram quantities of impurities could otherwise go unnoticed by conventional analytical techniques as hyphenated methods permit their detection. With combined mass spectrometry and chromatography, resolution is improved, high-throughput analysis enhanced, and even trace impurities are quantitated with greater accuracy at concentrations that may be extremely low. These techniques also clarify the impurity structure, which is important in identifying the potential hazards and how it impacts safety and stability with regards to patient care and the drug.
Keywords Hyphenated technique, LC-MS, GC-MS, LC-FTIR, GC-FTIR, Identification, Impurities, Impurity profile
Field Medical / Pharmacy
Published In Volume 7, Issue 3, May-June 2025
Published On 2025-05-27
DOI https://doi.org/10.36948/ijfmr.2025.v07i03.45307
Short DOI https://doi.org/g9mh93
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