A stability-indicating reverse phase–high performance liquid chromatography（RP–HPLC） method was developed and validated for the determination of atazanavir sulfate in tablet dosage forms using C_（18） column Phen...A stability-indicating reverse phase–high performance liquid chromatography（RP–HPLC） method was developed and validated for the determination of atazanavir sulfate in tablet dosage forms using C_（18） column Phenomenix（250 mm×4.6 mm, 5 μm） with a mobile phase consisting of 900 mL of HPLC grade methanol and100 mL of water of HPLC grade. The pH was adjusted to 3.55 with acetic acid. The mobile phase was sonicated for 10 min and filtered through a 0.45 μm membrane filter at a flow rate of 0.5 mL/min. The detection was carried out at 249 nm and retention time of atazanavir sulfate was found to be 8.323 min. Linearity was observed from 10 to 90 μg/mL（coefficient of determination R^2 was 0.999） with equation, y=23.427x＋37.732.Atazanavir sulfate was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation, and the results showed that it was more sensitive towards acidic degradation. The method was validated as per ICH guidelines.展开更多
美国FDA于2015年1月29日批准百时美施贵宝（Bristol Myers Squibb）公司的Atazanavir and Cobicistat（参考译名：阿扎那韦-可比司他，商品名：Evotaz）片剂上市，与其他抗逆转病毒药物合用于治疗人类免疫缺陷病毒（HIV）-1感染的成年...美国FDA于2015年1月29日批准百时美施贵宝（Bristol Myers Squibb）公司的Atazanavir and Cobicistat（参考译名：阿扎那韦-可比司他，商品名：Evotaz）片剂上市，与其他抗逆转病毒药物合用于治疗人类免疫缺陷病毒（HIV）-1感染的成年患者。展开更多
In the development of new drugs as well as new formulations of existing products(including generic products),it is of great interest to be able to predict to what extent the drug can be absorbed from the gastrointesti...In the development of new drugs as well as new formulations of existing products(including generic products),it is of great interest to be able to predict to what extent the drug can be absorbed from the gastrointestinal(GI)tract and how the formulation and dosing conditions may affect the absorption profile.The hypothesis behind Biorelevant release testing is that“the closer the test conditions can simulate the gastrointestinal environment,the better the prediction will be.”Typical aspects of GI physiology,which can influence drug bioavailability,are the composition of the GI fluids(which affects various processes including release from the dosage form and stability of the drug),GI motility and hydrodynamics(transit characteristics of the dosage form,release from the dosage form etc.).展开更多
文摘A stability-indicating reverse phase–high performance liquid chromatography（RP–HPLC） method was developed and validated for the determination of atazanavir sulfate in tablet dosage forms using C_（18） column Phenomenix（250 mm×4.6 mm, 5 μm） with a mobile phase consisting of 900 mL of HPLC grade methanol and100 mL of water of HPLC grade. The pH was adjusted to 3.55 with acetic acid. The mobile phase was sonicated for 10 min and filtered through a 0.45 μm membrane filter at a flow rate of 0.5 mL/min. The detection was carried out at 249 nm and retention time of atazanavir sulfate was found to be 8.323 min. Linearity was observed from 10 to 90 μg/mL（coefficient of determination R^2 was 0.999） with equation, y=23.427x＋37.732.Atazanavir sulfate was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation, and the results showed that it was more sensitive towards acidic degradation. The method was validated as per ICH guidelines.
文摘In the development of new drugs as well as new formulations of existing products(including generic products),it is of great interest to be able to predict to what extent the drug can be absorbed from the gastrointestinal(GI)tract and how the formulation and dosing conditions may affect the absorption profile.The hypothesis behind Biorelevant release testing is that“the closer the test conditions can simulate the gastrointestinal environment,the better the prediction will be.”Typical aspects of GI physiology,which can influence drug bioavailability,are the composition of the GI fluids(which affects various processes including release from the dosage form and stability of the drug),GI motility and hydrodynamics(transit characteristics of the dosage form,release from the dosage form etc.).
