Development and validation of a stability indicating HPLC method to determine diltiazem hydrochloride in tablets and compounded capsules

Abstract

A stability indicating HPLC method to determine diltiazem hydrochloride (DTZ) in tablets and compounded capsules was developed and validated according to Brazilian and the International Conference on Harmonization (ICH) guidelines. The separation was carried out on a Purospher Star ® C18 (150 x 4.6 mm i.d., 5 µm particle size, Merck Millipore) analytical column. The mobile phase consisted of a 0.05% (v/v) trifluoroacetic acid aqueous solution and a 0.05% trifluoroacetic acid methanolic solution (44:56, v/v). The flow rate was 1.0 mL.min -1 with a run time of 14 minutes. The detection of DTZ and degradation products (DP) was performed at 240 nm, using a diode array detector. The method proved to be linear, precise, accurate, selective, and robust, and was adequate for stability studies and routine quality control analyses of DTZ in tablets and compounded capsules.

Interpol review of controlled substances 2016–2019

“…Diltiazem: 2016 A ternary hybrid matrix to prolong the release [ 155 ]; 2017 dissolution profiles of two diltiazem hydrochloride tablet formulations [ 156 ]; stability indicating HPLC method to determine diltiazem hydrochloride in tablets and compounded capsules [ 157 ]; 2019 voltammetric method for determination of diltiazem [ 158 ].…”

Diltiazem-tetraiodide bismuthate (III) based PVC membrane for selective determination of diltiazem hydrochloride

“…It is a peripheral and coronary vasodilator with limited negative inotropic 5 . Several analytical methods for the determination of diltiazem hydrochloride (DLT) have been reported in the literature using high performance liquid chromatography [6][7][8][9][10][11][12] , spectrophotometry [13][14][15] , and voltammetry 16,17 . A plastic selective PVC membrane based on diltiazem-tetraphenylborate ion-associate has been used for potentiometric determination of diltiazem HCl as well 18 .…”

Evaluation of a diltiazem cream preparation for estimation of degradation behavior

“…Diltiazem hydrochloride, chemically known as 1, 5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl), monohydrochloride, is a benzothiazepine calcium channel blocking agent and vasodilator. It is commonly used to treat cardiovascular diseases such as angina pectoris, hypertension, and cardiac arrhythmias that lowers the blood pressure and has effect on cardiac conduction [1,2,3].…”

“…Generally, oral preparations of diltiazem hydrochloride are used to treat angina and hypertension and topical form is known to be used in the treatment of chronic anal fissure (CAF) [1,4,5]. As suggested by Dhawan and Chopra, 2% topical diltiazem hydrochloride is the first line treatment in case of CAF [6].…”