stability-indicating methodrenal cell carcinomakinase inhibitorHPLCAxitinibBackground Axitinib (AXT) is a member of the new generation of the kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. Its therapeutic benefits depend on assuring the good-quality of its dosage forms ...
A properly designed and executed forced degradation study would generate an appropriate sample for development of stability indicating method.References [1] ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (revision 2), International Conference on Harmonization. Available ...
STABILITY-INDICATING HPLC METHOD FOR DETERMINATION OF DONEPEZILHYDROCHLORIDE IN PURE AND IN TABLET DOSAGE FORMS A sensitive, simple and accurate stability-indicating HPLC method has been developed and validated for determination of Donepezil hydrochloride (DP) in pur... GHA Ragab 被引量: 0发表: 2016...
The present work describes a novel stability-indicating method development and validation for separation and identification of degradation products, known and genotoxic impurities in recently FDA approved (Ibrutinib) an anti-cancer drug using RP-HPLC/PDA and QDa mass detectors. Separation of all ...
Drug stability assessment generally involves the testing of the drug substance or drug product using a stability-indicating method in order to establish the retest period (for pre-market stability) and shelf life (for commercial stability). Drug substance (also called the active pharmaceutical ...
An isocratic, sensitive and stability-indicating high performance liquid chromatographic (HPLC) method for separation and determination of the related substances of micafungin sodium was developed. The chromatographic separation was achieved on Agilent Zorbax SB-C18 column (250 x 4.6 mm, 5 m). Forced...
The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, and robustness. 展开 关键词: Development degradation guaifenesin impurity HPLC stability-indicating validation ...
A validated stability-indicating HPLC method has been reported for the determination of Ilaprazole in bulk drug and tablet. The drug was subjected to the various stress conditions as per the ICH guidelines. The degradation behavior of Ilaprazole was studied under hydrolytic, oxidative, ...
The molecule was stable in all the stress conditions such as acid, base, oxidation, heat and photolysis as per the recommendations of ICH guidelines. The method was proved to be robust with respect to changes in flow rate, pH and column temperature. The proposed method is found to be ...
A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic (RP-HPLC) method was developed for the estimation of Cabozantinib, using a reversed-phase C18 column (250 mm × 4.6 mm, 5 m) a mobile phase consisting of 0.1% Formic acid:acetonitrile:met...