Development and validation of a stability indicating method for quantification of the sesquiterpene lactone eremantholide C from Lychnophora trichocarpha (Brazilian arnica)

Henriques, Bárbara Oliveira; Saúde-Guimarães, Dênia Antunes; Caldeira, Tamires Guedes; Souza, Jacqueline de

doi:10.1016/j.bjp.2017.03.001

Cited by 3 publications

(2 citation statements)

References 13 publications

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“…HPTLC has higher sensitivity than TLC but less sensitive than HPLC. [32][33][34][35][36][37][38][39][40][41][42] Rufinamide, Roflimilast, Pragabalin, Nizatidine, Naftopidil, Dexamethasone and Moxifloxacin, Levocabastine, AMLO-VAL-HCTZ, Eremantholide C, Silymerin and curcumin, Sofosbuvir and Ledipasvir, n-acetyl cysteine, HPLC -DAD SIM [43][44][45][46][47][48][49][50][51][52][53][54] Diclofenac, Piracetam, Rivaroxaban, Ofloxacine & ornidazole UPLC SIM [55][56][57][58] Isoflavone aglycone in soybean UFLC SIM 59 Desonide HPTLC SIM 60 Loratadine, Clobetasol, TLC SIM [61][62] Nicardipine, Azilsartan medoxomil Pottasium, HPLC-MS SIM [63][64] Ezetimibe, Simavastatin, Zidovudine HPLC-MS/MS SIM [65][66][67] HPTLC has advantages over large no of the sample can apply on a single plate, and the amount of mobile phase required is small, so it has costeffective analysis. HPLC UV method is the most commonly used method for development of stability indicating method, but it has a limit of its detection ability; however it is more sensitive than TLC and HPTLC method.…”

Section: Analytical Instrument Used In Stability Indicating Methods Dementioning

confidence: 99%

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2019

IJPSR

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Stability of pharmaceuticals is defined as the ability to retain the quality, purity, Identity, and safety throughout the shelf life of products. It is of main concern because drug substance and products lose its Potency and quality after the time passes, due to change in environmental conditions such as temperature, light, and humidity. It is essential that quality of drugs should maintain throw out the life cycle of drug products for their safe and effective use. The need for constant monitoring of the drug substance and product for their quality and purity has the origin of the development of various stability testing methods. Stability testing now becomes a regulatory requirement for filing NDA and ANDA to USFDA and various regulatory agencies. Stability indicating methods had originated from advancement in various analytical instrument technologies. Stability indicating methods of drug substance and products have the ability for separation, identification, qualification, and quantification of all impurities associated with drug substance and drug product at any storage Conditions to give the exact concentration of drug substance or analyte at any time point over the shelf life of products and beyond. These are helpful to understand the degradation pathways as well as obtaining knowledge about impurities developed during processing which should not be present in drug products or have a specific limit, if present. The present review explored the importance, regulatory requirement, various analytical techniques used and some successfully developed stability indicating methods for different drug substance and drug products. INTRODUCTION: Drug substance is defined as an active ingredient which is used in the treatment and mitigation of various diseases and disorders whereas, drug products are defined as the different marketed formulations present for drug substance to take or easily administered in the patient for showing its required therapeutic effect.

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Section: Analytical Instrument Used In Stability Indicating Methods Dementioning

confidence: 99%

Untitled

2019

IJPSR

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“…Besides that, it does not present expressive degradation in neutral and oxidative conditions. However, degradation occurs in alkaline and acidic conditions …”

Section: Introductionmentioning

confidence: 99%

Polymorphic characterization and implications on biopharmaceutics properties of potential anti-inflammatory drug candidate eremantholide C from Lychnophora trichocarpha (Brazilian Arnica)

Caldeira

Saúde-Guimarães

Lacerda

et al. 2019

Journal of Pharmacy and Pharmacology

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Objectives To perform the polymorphic and physicochemical characterization of the potential anti‐inflammatory drug, eremantholide C (EREC), as well as to evaluate the influence of these characteristics on its biopharmaceutics classification. Methods Eremantholide C was obtained from chloroformic extract of Lychnophora trichocarpha and crystallized in two distinct solvents: chloroform (EREC 1) and ethyl acetate (EREC 2). To evaluate the polymorphism, EREC samples were submitted to melting point, purity, infrared spectroscopy, differential scanning calorimetry (DSC), X‐ray powder diffraction, optical microscopy and scanning electron microscopy analysis. In addition, EREC samples crystallized after intrinsic dissolution study were submitted to DSC and X‐ray powder diffraction analysis. Key findings EREC 1 showed fusion at 234.7–241.6 °C, while EREC 2 showed fusion at 238.6–243.7 °C. No polymorphic transitions were observed during the intrinsic dissolution experiment. A single sharp endothermic peak was obtained for the EREC samples. X‐ray diffraction showed no crystallographic differences between the EREC samples. EREC 1 and EREC 2 showed birefringence under polarized light and indefinite morphology; however, the shape of the crystals was common to the two samples. Conclusions Eremantholide C does not present classical or morphological polymorphism; therefore, there is no influence of crystalline transitions in the solubility and consequently in its biopharmaceutics classification and oral absorption process.

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