Isolation And Characterisation Of Rapamycin, Temsirolimus Regio Isomer (MONOESTER) And Temsirolimus Diester In Temsirolimus Drug

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dc.contributor.authorReddy, G. S.en_US
dc.contributor.authorRao, C. V. N.en_US
dc.date.accessioned2020-09-24T08:00:50Z
dc.date.available2020-09-24T08:00:50Z
dc.date.issued2019-02
dc.description.abstractObjective: Separation and identification of the process impurities in the manufacture of temsirolimus drug viz., rapamycin, temsirolimus regioisomer (monoester) (TS monoester), and temsirolimus diester (TS diester). Methods: During the process development of temsirolimus (TS), three process impurities-rapamycin, temsirolimus regioisomer (monoester) and temsirolimus diester-were detected by high-performance liquid chromatography (HPLC). Impurities were isolated by medium pressure liquid Chromatography (MPLC) and characterized by ESI-MS/MS, 1H NMR, FT-IR spectral data. Results: These impurities are characterised with the help of ESI MS/MS, 1H NMR, and FT-IR data. The impurities are identified and characterised as the process impurities. One of them is the starting material i.e. rapamycin and the other two are formed during the manufacture of the drug. This method offers advantages over using photodiode-array UV detection (LC-PDA) for the determination of peak purity, viz. components with similar UV spectra can be distinguished. Conclusion: The structures of these impurities were characterized as rapamycin, TS Monoester, and TS Diester. Out of these process impurities, rapamycin has been previously identified while the other two are previously unreported.en_US
dc.identifier.affiliationsNRI Institute of Technology, Pothavarappadu, Agiripalli Mandal, Krishna District, A. P., India, 521212en_US
dc.identifier.affiliationsNRI Institute of Technology, Pothavarappadu, Agiripalli Mandal, Krishna District, A. P., India, 521212en_US
dc.identifier.citationReddy G. S., Rao C. V. N.. Isolation And Characterisation Of Rapamycin, Temsirolimus Regio Isomer (MONOESTER) And Temsirolimus Diester In Temsirolimus Drug. International Journal of Pharmacy and Pharmaceutical Sciences. 2019 Feb; 11(2): 94-99en_US
dc.identifier.issn0975-1491
dc.identifier.issn2656-0097
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/205841
dc.languageenen_US
dc.publisherInnovare Academic Sciences Pvt. Ltd.en_US
dc.relation.issuenumber2en_US
dc.relation.volume11en_US
dc.source.urihttps://doi.org/10.22159/ijpps.2019v11i2.30169en_US
dc.subjectTemsirolimusen_US
dc.subjectRapamycinen_US
dc.subjectTemsirolimus regio isomer (monoester)en_US
dc.subjectTemsirolimus diesteren_US
dc.subjectProcess impuritiesen_US
dc.subjectCharacterisationen_US
dc.titleIsolation And Characterisation Of Rapamycin, Temsirolimus Regio Isomer (MONOESTER) And Temsirolimus Diester In Temsirolimus Drugen_US
dc.typeJournal Articleen_US
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