An analytical method for the detection of impurities in telmisartan tablets and telmisartan capsules

Abstract

The invention provides an analysis method for detecting impurities in telmisartan tablets and telmisartan capsules, belonging to the field of drug detection. The method provided by the invention can perform qualitative and quantitative analysis on impurities in Telmisartan tablets and Telmisartan capsules using ultra-high performance liquid chromatography, including impurity A, impurity B, impurity C, impurity E, impurity F, impurity Any one or more of G, impurity H and impurity I. Compared with traditional high-performance liquid chromatography, the ultra-high performance liquid chromatography adopted in the present invention shortens the analysis time, reduces the amount of solvent and reduces the analysis cost; no ion-pairing reagent is added in the mobile phase, which greatly prolongs the chromatographic column service life; the method can completely separate telmisartan from the above 8 kinds of telmisartan impurities, and has a good baseline and a high limit of quantification, which is more conducive to the qualitative and quantitative determination of the impurities in telmisartan capsules.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to an analysis method for detecting impurities in telmisartan tablets and telmisartan capsules. Background technique [0002] The chemical name of Telmisartan is 4'-[[4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl]methyl]-2 -Bibenzoic acid, the molecular formula is C 33 h 30 N 4 o 2 . This product is a specific non-peptide angiotensin II receptor antagonist, which can selectively block the binding of angiotensin II in vascular smooth muscle and adrenal gland to its receptor subtype AT1, thereby blocking vasoconstriction and aldosterone secretion. Secreted, produce antihypertensive effect. This product can reduce both systolic and diastolic blood pressure without affecting heart rate, has no partial agonist effect at the AT1 receptor site, does not inhibit the activity of angiotensin converting enzyme, and does not bind to or produce other receptors or ion channe...

AI Technical Summary

Problems solved by technology

[0063] Due to the large number of impurities related to telmisartan and their relatively similar structures, it brings great difficulties to the subsequent analysis and detection of impurities

Compared with the impurity detection technology of the quality standards of telmisartan in the existing pharmacopoeias of various countries, the European Pharmacopoeia, the British Pharmacopoeia, the United States Pharmacopoeia and the Japanese Pharmacopoeia are all determined by high performance liquid chromatography, and all adopt the gradient elution method, but none of the above The 8 kinds of telmisartan impurities were completely separated, and the baseline was poor, which affected the detection of impurities; moreover, sodium n-pentanesulfonate was added to the mobile phase of these impurity detection technologies, which belonged to ion-pair reagents, and ion-pair reagents would Cause irreversible damage to the chromatographic column, the combination of ion-pairing reagent and stationary phase will produce irreversible adsorption, and then affect the active site of the stationary phase; such as octadecyl silica gel bonded column, ion-pairing reagent will affect the bonding of the column, so as to Analysis of the role of the sample, this reaction has a great impact on the chromatographic column, and the ion-pairing reagent is difficult to wash from the chromatographic column, which will greatly shorten the service life of the chromatographic column; the concentration of the ion-pairing reagent has a direct relationship with the retention time of the sample In addition, ion-pair reagents are more sensitive to the pH value, and high precision is required when preparing the mobile phase, otherwise it will directly affect the repeatability and reproducibility of the experiment

Although no ion-pairing reagent is added to the mobile phase of Telmisartan in Chinese Pharmacopoeia, this chromatographic condition is only used to detect impurity I, and cannot completely detect and separate the above 8 kinds of Telmisartan impurities

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