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Asian Journal of Pharmaceutical Analysis
Year : 2017, Volume : 7, Issue : 1
First page : ( 31) Last page : ( 35)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2017.00006.0

Identification of Impurities and Degradation Products in Pharmaceutical Products-Role of Hyphenated Techniques

Khan Hamid1,*, Ali Javed2

1JK College of Pharmacy, Bilaspur, Chhattisgarh India-495001

2Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, New Delhi, India-110062

*Corresponding Author E-mail: khanhamid770@gmail.com

Online published on 18 September, 2017.

Abstract

Impurity profiling and identification of degradation product is an essential part of pharmaceutical development program. Impurity profiling is mandatory requirement by various regulatory agencies and is directly related with the quality, safety and efficacy of a drug product. The ultimate purpose of impurity profiling and stress testing is in the establishment of the degradation products pathways and to investigate the stability-indicating power of the analytical procedures which is ultimately helpful in the prediction of shelf life of drug product. Hyphenated technique is combination a combination of two different analytical techniques with the help of proper interface. Mainly chromatographic techniques are combined with the spectroscopic techniques. This write up provides a review on brief information about role of different hyphenated analytical techniques such as HPLC-UV, HPLC-MS, GC-MS and UPLC-MS/MS for identification of impurities and degradation products in pharmaceutical products.

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Keywords

Identification, Impurities, Degradation Products, Stress Testing, Analytical Techniques.

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