A method for separating and determining related substances of ipagliflozin proline bulk drug by HPLC
A related substance, proline technology, applied in the field of analysis and determination of ipagliflozin proline raw material drug, can solve the problems of no fast, simple and accurate analysis and detection, and achieve the effect of high sensitivity
Active Publication Date: 2018-08-14
安徽联创生物医药股份有限公司
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Problems solved by technology
[0007] In order to control the quality of ipagliflozin proline raw material drug, it is necessary to control the main components and impurities. Analytical Methods of Substances
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[0020] The present invention will be described in detail below in conjunction with specific embodiments. The following examples will help those skilled in the art to further understand the present invention, but do not limit the present invention in any form. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention. These all belong to the protection scope of the present invention.
[0021] Relevant substance gets this product appropriate amount, and solvent (acetonitrile-water (40:60)) dissolves and quantitatively dilutes and makes the solution that contains Ipagliflozin about 0.4mg in every 1ml, as need testing solution; Precision measures 1mL, Put it in a 200mL measuring bottle, add solvent to dilute to the mark, shake well, and use it as a control solution. Separately take appropriate amount of reference substances of Ixagliflozin, impurity A, impurity B, impurity C, impur...
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Abstract
The invention relates to a method for measuring related substances in ipragliflozin proline bulk pharmaceutical chemicals through HPLC separation. The method comprises the steps of conducting gradient elution with octadecyl silane bonded silica gel as filler, water as mobile phase A and acetonitrile as mobile phase B, and detecting ipragliflozin by means of an ultraviolet detector, wherein flow rate is 0.8-1.2 mL / min, and column temperature is 28-32 DEG C; detecting proline by means of the ultraviolet detector with octadecyl silane bonded silica gel as filler and methyl alcohol and water mixed liquid as mobile phase. Comprehensive influences of an analytical column, the mobile phases, gradient elution, flow rate and column temperature on separation detection are comprehensively considered, so that a detection result is optimized. The method has the advantages of being quick, convenient to use, high in sensitivity, accurate and reliable, and is suitable for separation measurement of related substances in ipragliflozin proline bulk pharmaceutical chemicals.
Description
technical field [0001] The invention relates to an analysis and determination method of an ipagliflozin proline crude drug, in particular to a method for separating and measuring related substances of the ipagliflozin proline crude drug by HPLC. Background technique [0002] With the trend of population aging and changes in lifestyle, the number of patients with type 2 diabetes who are closely related to nutrition and exercise is increasing year by year in our country, mainly with type 2 diabetes. Traditional diabetes treatment drugs often have some adverse reactions, such as weight gain and hypoglycemia. SGLT2 is a new target for diabetes treatment. SGLT2 inhibitors can excrete excess glucose from the urine, thereby reducing glycosylated proteins, improving insulin sensitivity in the liver and peripheral tissues, improving β-cell function, and further improving liver insulin. Resistance, thereby promoting the normalization of higher glycogen output and reducing the elevate...
Claims
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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 葛德培吴其华刘涛
Owner 安徽联创生物医药股份有限公司