Method for detecting related substances of tamsulosin hydrochloride sustained-release capsule
A technology of tamsulosin hydrochloride and sustained-release capsules is applied in the detection of tamsulosin hydrochloride sustained-release capsules, and high-performance liquid chromatography is used to detect related substances in tamsulosin hydrochloride sustained-release capsules, which can solve the problem of the main peak peak time. Fast, poor separation effect, large differences in main drug dissolution, etc., to achieve the effects of good precision and durability, quality assurance, and stable and reliable results
Pending Publication Date: 2022-07-01
LUNAN PHARMA GROUP CORPORATION
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[0009] After research, it is found that in the actual operation process, the above method has the following disadvantages: the time for the main peak to emerge is relatively fast, and the separation effect between the excipient peaks and the impurity peaks is poor. Through the comparison of tamsulosin hydrochloride sustained-release capsules from different manufacturers, Using 1M hydrochloric acid methanol as a solvent, the preparation process of different drugs, the dissolution of the main drug is quite different
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[0044] A method for detecting related substances of tamsulosin hydrochloride sustained-release capsules, comprising the following steps:
[0045] Step 1: Prepare the sample solution,
[0046](1) The test solution is: take 10 tamsulosin hydrochloride sustained-release capsules, pour out the contents, put it in a 50ml measuring bottle, add 20mL of sodium hydroxide solution (1g→500ml), and heat it in a water bath at 50°C for 10 After 10 minutes, shake it thoroughly for 30 minutes, add 10 ml of acetonitrile, accurately add 5.5 ml of 0.2mol / L hydrochloric acid solution, shake well for 30 minutes, add acetonitrile-water (3:7) to the volume, shake well, centrifuge, Take the supernatant as the test solution.
[0047] (2) Control solution: Precisely measure 1mL of the above test solution, put it in a 500mL volumetric flask, add mobile phase to dilute to the mark, and shake well.
[0048] (3) System suitability solution: Take appropriate amount of tamsulosin hydrochloride reference su...
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Abstract
The invention belongs to the field of pharmaceutical analysis, relates to a method for detecting related substances of tamsulosin hydrochloride sustained-release capsules, and particularly relates to a method for detecting related substances of tamsulosin hydrochloride sustained-release capsules by using a high performance liquid chromatography, which comprises the following steps: using a C18 column as a chromatographic column, using a buffer solution with the pH value of 1.5-3.0 as a mobile phase A, using acetonitrile as a mobile phase B, carrying out gradient elution, and controlling the detection wavelength to be 200-280nm. The detection method provided by the invention can effectively detect related substances in the tamsulosin hydrochloride sustained-release capsule, and has the advantages of high sensitivity, good separation degree, high precision and durability, simple operation and stable result, so that the method can be used for controlling impurities in the tamsulosin hydrochloride sustained-release capsule, and a powerful guarantee is provided for the product quality.
Description
technical field [0001] The invention relates to a detection method for tamsulosin hydrochloride sustained-release capsules, in particular to a method for detecting related substances in tamsulosin hydrochloride sustained-release capsules by high performance liquid chromatography, and belongs to the field of drug analysis. Background technique [0002] Prostatic hyperplasia, also known as benign prostatic hyperplasia, is the most common disease that causes urination disorders in middle-aged and elderly men. Histologically, it is an increase in interstitial and glandular components. The main clinical manifestations are frequent urination, urgency, increased frequency of nocturia, and labored urination. In addition, benign prostatic hyperplasia may also lead to complications such as urinary tract infection, bladder stones, hematuria, and urinary retention. Tamsulosin Hydrochloride Sustained-Release Capsules is a commonly used drug for the treatment of benign prostatic hyperpla...
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IPC IPC(8): G01N3/02G01N3/06G01N30/54G01N30/74
CPCG01N3/02G01N3/06G01N30/54G01N30/74
Inventor 袁丹赵文杰刘阿利
Owner LUNAN PHARMA GROUP CORPORATION
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