4 results about "Tandospirone" patented technology

The invention relates to the field of pharmaceutical analytical chemistry, in particular to a method for determining tandospirone and salt intermediates thereof, high performance liquid chromatography is adopted, and chromatographic conditions include that a chromatographic column with octadecylsilane chemically bonded silica as a filler is adopted, and gradient elution is performed by a mobile phase A and a mobile phase B; wherein the mobile phase A consists of a first water phase and acetonitrile; the mobile phase B is composed of a second water phase and acetonitrile; the first water phase is a water solution containing monopotassium phosphate and sodium hexanesulfonate, and the pH value of the first water phase is 3.0-3.8; the second water phase is an aqueous solution containing monopotassium phosphate and sodium hexanesulfonate, and the pH value of the second water phase is 1.8-2.6. The testing method disclosed by the invention has good specificity, accuracy and repeatability, and can be used for monitoring the quality of the tandospirone raw material medicine.

The present application relates to the field of pharmaceutical analysis chemistry, and specifically provides a determination method of tandospirone and salt intermediates, which adopts high performance liquid chromatography, and the chromatographic conditions include: adopting a chromatographic column with octadecylsilane bonded silica gel as a filler, and gradient elution is performed with mobile phase A and mobile phase B; wherein, the mobile phase A is composed of a first water phase and acetonitrile; the mobile phase B is composed of a second water phase and acetonitrile; the first water phase is an aqueous solution containing potassium dihydrogen phosphate and sodium hexanesulfonate, and the pH is 3.0-3.8; the second water phase is an aqueous solution containing potassium dihydrogen phosphate and sodium hexanesulfonate, and the pH is 1.8-2.6. The test method has good specificity, accuracy and repeatability, and can be used for quality monitoring of tandospirone bulk drug.

The present invention relates to a transdermal absorption preparation that can maintain a blood concentration sufficient to exert the efficacy of tandospirone, and also shows good storage stability against heat, humidity, and light. According to the present invention, a transdermal absorption preparation containing tandospirone or a pharmaceutically acceptable salt thereof, and levulinic acid, which is superior in the skin permeability of tandospirone or a pharmaceutically acceptable salt thereof in the preparation, and shows good preservation stability against heat and light can be provided.

The invention discloses a high performance liquid chromatography method for detecting related substances in a tandospirone citrate bulk drug. According to the method, a chromatographic column is an octadecyl silane bonded silica gel packed column; the mobile phase A is a mixed solution of a buffer system with the pH value of 2.5-4.5 and acetonitrile, the mobile phase B is a mixed solution of a buffer system with the pH value of 1.5-3.0 and acetonitrile, gradient elution is adopted, dual-wavelength detection can be adopted, the first detection wavelength is 220-250 nm, and the second detection wavelength is 190-215 nm. The method can simultaneously separate and detect various related substances in the bulk drug, has the characteristics of strong specificity, high sensitivity, good repeatability, simplicity and convenience in operation and the like, and can be used for quality control of the tandospirone citrate bulk drug.