“…10 There have been a number of reported thin layer (TLC) and gas (GC) chromatographic methods for cyclobenzaprine HCl. 11 Few HPLC methods for the characterization of cyclobenzaprine HCl drug substance and products have been reported in part due to early drug development having been completed prior to HPLC being a generally accepted chromatographic method and in part due to its poor elution characteristics with old reversed-phase columns. 11 Recently, novel formulations have been developed to meet special patient needs and/or new applications.…”
Section: Introductionmentioning
confidence: 99%
“…11 Few HPLC methods for the characterization of cyclobenzaprine HCl drug substance and products have been reported in part due to early drug development having been completed prior to HPLC being a generally accepted chromatographic method and in part due to its poor elution characteristics with old reversed-phase columns. 11 Recently, novel formulations have been developed to meet special patient needs and/or new applications. [20][21][22][23] For the renewed interests in novel formulations currently under development, there is a need to study drug degradation by using state-of-the-art technologies in a systematic manner.…”
Section: Introductionmentioning
confidence: 99%
“…Although there have been several reported papers describing the cyclobenzaprine degradation in vivo (drug metabolism), [12][13][14][15][16][17][18][19] there has been very little published data on the cyclobenzaprine degradation in vitro. 11 Current literature indicates that degradation of cyclobenzaprine occurred primarily by an oxidative process under severe stressed conditions in the aqueous solution. The reported degradants of cyclobenzaprine HCl in acidic aqueous solution identied by HPLC include only exocyclic epoxide, dibenzosuberenone, and anthraquinone.…”
Section: Introductionmentioning
confidence: 99%
“…The reported degradants of cyclobenzaprine HCl in acidic aqueous solution identied by HPLC include only exocyclic epoxide, dibenzosuberenone, and anthraquinone. 11 Exocyclic epoxide has been viewed as one of the initial degradants while dibenzosuberenone and anthraquinone have been regarded as the nal results of the degradation. 11 A large number of intermediate degradation products have not been identied yet.…”
Section: Introductionmentioning
confidence: 99%
“…11 Exocyclic epoxide has been viewed as one of the initial degradants while dibenzosuberenone and anthraquinone have been regarded as the nal results of the degradation. 11 A large number of intermediate degradation products have not been identied yet. The elucidation of these intermediate degradants can provide detailed structural evidences for drug degradation pathways.…”
A systematic forced degradation study of cyclobenzaprine for the elucidation of the degradation mechanism was carried out to support the new formulation development.
“…10 There have been a number of reported thin layer (TLC) and gas (GC) chromatographic methods for cyclobenzaprine HCl. 11 Few HPLC methods for the characterization of cyclobenzaprine HCl drug substance and products have been reported in part due to early drug development having been completed prior to HPLC being a generally accepted chromatographic method and in part due to its poor elution characteristics with old reversed-phase columns. 11 Recently, novel formulations have been developed to meet special patient needs and/or new applications.…”
Section: Introductionmentioning
confidence: 99%
“…11 Few HPLC methods for the characterization of cyclobenzaprine HCl drug substance and products have been reported in part due to early drug development having been completed prior to HPLC being a generally accepted chromatographic method and in part due to its poor elution characteristics with old reversed-phase columns. 11 Recently, novel formulations have been developed to meet special patient needs and/or new applications. [20][21][22][23] For the renewed interests in novel formulations currently under development, there is a need to study drug degradation by using state-of-the-art technologies in a systematic manner.…”
Section: Introductionmentioning
confidence: 99%
“…Although there have been several reported papers describing the cyclobenzaprine degradation in vivo (drug metabolism), [12][13][14][15][16][17][18][19] there has been very little published data on the cyclobenzaprine degradation in vitro. 11 Current literature indicates that degradation of cyclobenzaprine occurred primarily by an oxidative process under severe stressed conditions in the aqueous solution. The reported degradants of cyclobenzaprine HCl in acidic aqueous solution identied by HPLC include only exocyclic epoxide, dibenzosuberenone, and anthraquinone.…”
Section: Introductionmentioning
confidence: 99%
“…The reported degradants of cyclobenzaprine HCl in acidic aqueous solution identied by HPLC include only exocyclic epoxide, dibenzosuberenone, and anthraquinone. 11 Exocyclic epoxide has been viewed as one of the initial degradants while dibenzosuberenone and anthraquinone have been regarded as the nal results of the degradation. 11 A large number of intermediate degradation products have not been identied yet.…”
Section: Introductionmentioning
confidence: 99%
“…11 Exocyclic epoxide has been viewed as one of the initial degradants while dibenzosuberenone and anthraquinone have been regarded as the nal results of the degradation. 11 A large number of intermediate degradation products have not been identied yet. The elucidation of these intermediate degradants can provide detailed structural evidences for drug degradation pathways.…”
A systematic forced degradation study of cyclobenzaprine for the elucidation of the degradation mechanism was carried out to support the new formulation development.
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