Related substance analysis method of terazosin hydrochloride tablets
A technology of terazosin hydrochloride tablets and related substances, which is applied in the field of analysis and detection of related substances of terazosin hydrochloride tablets, can solve problems such as no reports of terazosin hydrochloride tablets, and achieve qualified inspection and peak purity , high yield effect
Active Publication Date: 2016-07-13
南京易亨制药有限公司
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Abstract
The invention discloses a related substance analysis method of terazosin hydrochloride tablets. A related substance is reported for the first time. A preparation method comprises the following steps: damaging a terazosin hydrochloride crude drug under the condition of 80 DEG C to 90 DEG C for 36 to 48 hours; dissolving the sample which is damaged at the high temperature into a methanol-water solution with the methanol volume percent concentration of 70 percent to 90 percent; stirring and filtering through suction; collecting filtrate, and decompressing and concentrating to obtain a concentrate; carrying out chromatographic separation on the concentrate with a normal-phase silica gel column, and carrying out gradient elution with a chloroform-methanol mixed solvent at the volume ratio of (5:1) to (2:1); collecting 8th to 14th column volume eluting solutions and concentrating to obtain a rough product; purifying the rough product with a reversed-phase silica gel column, wherein a fixed phase is octadecyl silane bonded silica gel and a mobile phase is acetonitrile-water with the acetonitrile volume percent concentration of 80 percent to 90 percent; carrying out gradient elution and collecting 7th to 11th column volume eluting solutions, and concentrating, freezing and drying. The preparation method is simple and feasible. The liquid-phase analysis method provided by the invention can be used for effectively separating the chromatographic peak of the related substance and the chromatographic peak of terazosin.
Application Domain
Organic chemistryComponent separation
Technology Topic
SolventChemistry +14
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PUM
Property | Measurement | Unit |
Wavelength | 246.0 | nm |
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