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1 Sukumar Nandiet al,IJCPS,2016,4(9):479 482 CODEN (USA): IJCPNH|ISSN: 2321-3132 International Journal of Chemistry and Pharmaceutical Sciences479 International Journal of Chemistry andPharmaceutical SciencesJournal Home ArticleOpenAccessDegradationImpuritiesin Linagliptin Drug ProductNaresh Akkinaa, Bala Narasimha Reddy Gonaa,B. Venkateswara Raob, Paul Douglas Sanasib,Sukumar Nandi*aaDepartment of Chemical Research and Development, Aurobindo Pharma limited., Survey No. 71& 72, Indrakaran Village,Sangareddy Mandal, Medak District-502 329, Telangana, of Engineering Chemistry, College of Engineering, Andhra University, Visakhapatnam-530003, AndhraPradesh, B S T R A C TThree degradationimpurities related to Linagliptin (1) drug product,N-Acetyl Linagliptin (2),N-Aminoacyl Linagliptin (3)andN-Formyl Linagliptin (4) have been synthetically prepared and characterized.

2 These impurities form due to interaction ofexcipient and active pharmaceutical ingredient (API) during formulation. Formation of above drug product degradationimpurities has been :Linagliptin, excipient, drug product, degradation, impuritiesA R T I C L EI N F .. and Discussion..482 Article History:Received25 May2016,Accepted19 July2016,Available Online27 September2016 PAPER-QRCODEC itation:Dr. Sukumar Nandi,et Impurities in Linagliptin Drug J. Chem, Pharm, Sci., 2016,4(9) 2016Dr. Sukumar Nandi,et is an open- Access Article distributed under the terms of theCreative CommonsAttribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original workis IntroductionDegradation products in drug product formulations aresought to be tightly controlled by pharmaceutical upon the drug s maximum daily dose,regulatory guidelines require the characterization andtoxicological evaluation of degradationimpurities.

3 Drugdegradation of products is generated by interaction of many*Corresponding AuthorDr. Sukumar Nandi,Department of Chemical Research andDevelopment, Aurobindo Pharma limited,Survey No. 71 &72, Sangareddy,Medak-502 329, Telangana, ID: IJCPS3101 Sukumar Nandiet al,IJCPS,2016,4(9):479 482 CODEN (USA): IJCPNH|ISSN: 2321-3132 International Journal of Chemistry and Pharmaceutical Sciences479 International Journal of Chemistry andPharmaceutical SciencesJournal Home ArticleOpenAccessDegradationImpuritiesin Linagliptin Drug ProductNaresh Akkinaa, Bala Narasimha Reddy Gonaa,B.

4 Venkateswara Raob, Paul Douglas Sanasib,Sukumar Nandi*aaDepartment of Chemical Research and Development, Aurobindo Pharma limited., Survey No. 71& 72, Indrakaran Village,Sangareddy Mandal, Medak District-502 329, Telangana, of Engineering Chemistry, College of Engineering, Andhra University, Visakhapatnam-530003, AndhraPradesh, B S T R A C TThree degradationimpurities related to Linagliptin (1) drug product,N-Acetyl Linagliptin (2),N-Aminoacyl Linagliptin (3)andN-Formyl Linagliptin (4) have been synthetically prepared and characterized.

5 These impurities form due to interaction ofexcipient and active pharmaceutical ingredient (API) during formulation. Formation of above drug product degradationimpurities has been :Linagliptin, excipient, drug product, degradation, impuritiesA R T I C L EI N F .. and Discussion..482 Article History:Received25 May2016,Accepted19 July2016,Available Online27 September2016 PAPER-QRCODEC itation:Dr. Sukumar Nandi,et Impurities in Linagliptin Drug J. Chem, Pharm, Sci., 2016,4(9) 2016Dr. Sukumar Nandi,et is an open- Access Article distributed under the terms of theCreative CommonsAttribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original workis IntroductionDegradation products in drug product formulations aresought to be tightly controlled by pharmaceutical upon the drug s maximum daily dose,regulatory guidelines require the characterization andtoxicological evaluation of degradationimpurities.

6 Drugdegradation of products is generated by interaction of many*Corresponding AuthorDr. Sukumar Nandi,Department of Chemical Research andDevelopment, Aurobindo Pharma limited,Survey No. 71 &72, Sangareddy,Medak-502 329, Telangana, ID: IJCPS3101 Sukumar Nandiet al,IJCPS,2016,4(9):479 482 CODEN (USA): IJCPNH|ISSN: 2321-3132 International Journal of Chemistry and Pharmaceutical Sciences479 International Journal of Chemistry andPharmaceutical SciencesJournal Home ArticleOpenAccessDegradationImpuritiesin Linagliptin Drug ProductNaresh Akkinaa, Bala Narasimha Reddy Gonaa,B.

7 Venkateswara Raob, Paul Douglas Sanasib,Sukumar Nandi*aaDepartment of Chemical Research and Development, Aurobindo Pharma limited., Survey No. 71& 72, Indrakaran Village,Sangareddy Mandal, Medak District-502 329, Telangana, of Engineering Chemistry, College of Engineering, Andhra University, Visakhapatnam-530003, AndhraPradesh, B S T R A C TThree degradationimpurities related to Linagliptin (1) drug product,N-Acetyl Linagliptin (2),N-Aminoacyl Linagliptin (3)andN-Formyl Linagliptin (4) have been synthetically prepared and characterized.

8 These impurities form due to interaction ofexcipient and active pharmaceutical ingredient (API) during formulation. Formation of above drug product degradationimpurities has been :Linagliptin, excipient, drug product, degradation, impuritiesA R T I C L EI N F .. and Discussion..482 Article History:Received25 May2016,Accepted19 July2016,Available Online27 September2016 PAPER-QRCODEC itation:Dr. Sukumar Nandi,et Impurities in Linagliptin Drug J. Chem, Pharm, Sci., 2016,4(9) 2016Dr. Sukumar Nandi,et is an open- Access Article distributed under the terms of theCreative CommonsAttribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original workis IntroductionDegradation products in drug product formulations aresought to be tightly controlled by pharmaceutical upon the drug s maximum daily dose,regulatory guidelines require the characterization andtoxicological evaluation of degradationimpurities.

9 Drugdegradation of products is generated by interaction of many*Corresponding AuthorDr. Sukumar Nandi,Department of Chemical Research andDevelopment, Aurobindo Pharma limited,Survey No. 71 &72, Sangareddy,Medak-502 329, Telangana, ID: IJCPS3101 Sukumar Nandiet al,IJCPS,2016,4(9):479 482 CODEN (USA): IJCPNH|ISSN: 2321-3132 International Journal of Chemistry and Pharmaceutical Sciences480excipient and active pharmaceutical ingredients (API) [1-2].Many of the API s involves hydrolysis, oxidation orspecific interaction of drugs with reactive impurities inexcipient [3-5].

10 Understanding the excipient (reactiveimpurity sources) and its impact on the drug productstability is essential in designing and developing a robustdrug product [6-7]. As a part of ongoing Research onLinagliptin (1) drug product formulation,we envisagedformation of three degradation impurities, namelyN-AcetylLinagliptin (2),N-Aminoacyl Linagliptin (3) andN-FormylLinagliptin (4).2. ExperimentalReagentsAcetyl chloride, triethyl amine, acetic anhydride, Formicacid and urea were used as raw materials. Linagliptin usedfor the preparation of impurities was prepared as per theliterature reported method.