Etoricoxib is a selective COX-2 inhibitor and used as a non-steroidal anti-inflammatory drug. A new validated stability indicating RP-UFLC method has been developed for the estimation of Etoricoxib in pharmaceutical dosage forms (Tablets). Shimadzu UFLC system (PDA detector) with Agilent C18 column was chosen for the chromatographic study with mobile phase Acetonitrile: water (50: 50) and flow rate 0.8 mL/min (UV detection at 230 nm). Beer-Lambert’s law was obeyed over a concentration range 0.1-100 µg/mL. The linear regression equation was found to be y = 82642x -13032 (R2 = 0.9998). The LOD and LOQ was found to be and 0.0291 and 0.0894 µg/mL respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines. The proposed method is simple, precise, accurate and robust and can be applied for the quantification of Etoricoxib formulations.
Gefitinib is an anticancer drug used for the treatment of lung cancer, breast cancer and prostate cancer. A new stability indicating RP-HPLC method was proposed for the estimation of Gefitinib in pharmaceutical dosage forms (tablets). Shimadzu Model CBM-20A/20 Alite HPLC system with PDA detector and Agilent C18 column were used for the chromatographic study. Mobile phase mixture consisting of Tetra butyl ammonium hydrogen sulphate and Methanol in the ratio 50:50, v/v with a flow rate 0.8 mL/min was chosen for the chromatographic elution of Gefitinib (Detection wavelength 340 nm). The method was linear over the concentration range 0.1-80 mg/mL with linear regression equation, y = 70782x + 6171.6 (R² = 0.9999). The LOD and LOQ were found to be 0.2931 mg/mL and 0.8947 mg/mL respectively. Stress degradation studies were performed by exposing Gefitinib to various stress conditions and the method was validated as per ICH guidelines.
Clofarabine is an anti-cancer drug. A new stability indicating isocratic RP-HPLC and LC-APCI-MS methods have been developed and validated for the quantification of Clofarabine as per ICH guidelines. Thermo scientific-TSQ Quantis with Vanquish HPLC coupled with MS was employed for the present study. Simpack C18 column was used for chromatographic resolution and a triple quadrupole mass spectrometer with atmospheric pressure chemical ionization (APCI) source, running in the positive mode (as well as negative mode) was used for detection. A mixture of 0.1% Formic acid: Acetonitrile was used as mobile phase on gradient mode and a mixture of Methanol: Water (50:50, v/v) was used as diluent. A wide linearity concentration range 5.0-150 μg/mL was shown by the proposed method. The proposed methods are simple, precise, and accurate are used to quantify the marketed formulations of Clofarabine. Stress degradation studies were performed and the method is found to be selective and specific.
Efavirenz is an active non-nucleoside reverse transcriptase inhibitor used for the treatment of human immunodeficiency virus (HIV) type 1. A simple and validated new stability indicating RP-UFLC method has been developed for the estimation of Efavirenz in pharmaceutical dosage forms i. e. tablets. Shimadzu UFLC system (PDA detector) with Zorbox C18 column was chosen for the chromatographic study with flow rate 1.2 mL/min (UV detection at 252 nm). Beer-Lambert’s law was obeyed over a concentration range 0.05-160 µg/mL. The linear regression equation was found to be y = 44317x + 8491.1 (R2 = 0.9993). The LOD and LOQ was found to be 0.0142 and 0.0429 µg/mL respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines. The proposed method is simple, precise, accurate and robust and can be applied for the quantification of Efavirenz formulations.
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