High-Performance Liquid Chromatography Method for Assay of Diltiazem Hydrochloride and Its Related Compounds in Bulk Drug and Finished Tablets

Lacroix, Pauline M.; Beaulieu, Normand; Cyr, Terry D.; Lovering, Edward G

doi:10.1002/jps.2600780315

Cited by 15 publications

(7 citation statements)

References 10 publications

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“…An HPLC method for assay of Diltiazem Hydrochloride and its related substances (RS) in bulk drug and finished tablets is reported [26] without any comment on the stability indicating potential of the method.…”

Section: Introductionmentioning

confidence: 99%

Validated gradient stability indicating HPLC method for determining Diltiazem Hydrochloride and related substances in bulk drug and novel tablet formulation

Chatpalliwar¹,

Porwal²,

Upmanyu

2012

Journal of Pharmaceutical Analysis

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A stability-indicating liquid chromatographic method has been developed and validated for the determination of Diltiazem Hydrochloride (DTZ) together with its six related substances (Diltiazem sulphoxide, Imp-A, Imp-B, Imp-D, Imp-E, and Imp-F) in a laboratory mixture as well as in a novel tablet formulation developed in-house. Efficient chromatographic separation was achieved on a Hypersil BDS C18 (150 mm×4.6 mm, 5.0 μm) with mobile phase containing 0.2% Triethylamine (TEA) in gradient combination with acetonitrile (ACN) at a flow rate of 1.0 mL/min and the eluent was monitored at 240 nm. In the developed method, the resolution of DTZ from any pair of impurities was found to be greater than 2.0. The test solution and related substances were found to be stable in the diluent for 24 h. The developed method resolved the drug from its known impurities, stated above, and also from additional impurities generated when the formulation was subjected to forced degradation; the mass balance was found close to 99.9%.Regression analyses indicate correlation coefficient value greater than 0.997 for DTZ and its six known impurities. The LOD for DTZ and the known impurities was at a level below 0.02%. The method has shown good, consistent recoveries for DTZ (99.8–101.2%) and also for its six known impurities (97.2–101.3%). The method was found to be accurate, precise, linear, specific, sensitive, rugged, robust, and stability-indicating.

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Section: Introductionmentioning

confidence: 99%

Validated gradient stability indicating HPLC method for determining Diltiazem Hydrochloride and related substances in bulk drug and novel tablet formulation

Chatpalliwar¹,

Porwal²,

Upmanyu

2012

Journal of Pharmaceutical Analysis

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“…The assay procedure listed in British Pharmacopoeia [3] and USP (Id acronym at 1 st usage) [4], where in the drug and its formulations are estimated by an HPLC (Id) method. The other methods for its estimation include gas chromatography (GC) [5,6], capillary GC [7], capillary electrophoresis [8], Raman spectroscopy [9], voltammetry and amperometry [10], HPLC [11][12][13][14][15][16][17][18][19][20][21][22][23], colorimetry [24,25], and spectrophotometry [26][27][28][29][30][31][32]. The present work describes the optimization of conditions for the determination of diltiazem hydrochloride in bulk and tablet formulations through oxidation-reduction reactions.…”

Section: Introductionmentioning

confidence: 99%

Indirect spectrophotometric determination of diltiazem hydrochloride in pure form and pharmaceutical formulations

El‐Didamony

2005

Open Chemistry

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Three simple, accurate, and sensitive spectrophotometric methods (A, B and C) have been described for the indirect assay of diltiazem hydrochloride (DIL.HCl), either in pure form or in pharmaceutical formulations. The first method (A) is based on the oxidation of DIL.HCl by N-bromosuccinimide (NBS) and determination of unconsumed NBS by measuring the decrease in absorbance of amaranth dye (AM) at a suitable λ max = 521 nm. Other methods (B) and (C) involve the addition of excess cerric ammonium sulfate (CAS) and subsequent determination of the unconsumed oxidant by a decrease in the red color of chromotrope 2R (C2R) at a suitable λ max = 528 nm or a decrease in the orange-pink color of rhodamine 6G (Rh6G) at λ max = 525 nm, respectively. Regression analysis of Beer-Lambert plots showed good correlation in the concentration ranges 3.0 -9.0, 3.5 -7.0 and 3.5 -6.3 µg ml −1 for methods A, B and C, respectively. The apparent molar absorptivity, Sandell's sensitivity, detection and quantification limits were calculated. The proposed methods have been applied successfully for the analysis of the drug in its pure form and its dosage form. No interference was observed from a common pharmaceutical adjuvant. Statistical comparison of the results with the reference method shows excellent agreement and indicates no significant difference in accuracy and precision.

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“…Trans-Diltiazem, 7 known, and several unknown related compounds were separated from diltiazem-HCl. Minimum detectable amount and the relative standard deviation of the assay procedure were 0.1 and 0.15%, respectively [53]. [58] an estimation of diltiazem in plasma using normal-phase column liquid chromatography with ultraviolet detection.…”

Section: Hplc Methods At Present Hplc Is the Most Widelymentioning

confidence: 98%

An Overview of Analytical Determination of Diltiazem, Cimetidine, Ranitidine, and Famotidine by UV Spectrophotometry and HPLC Technique

Shafi

Siddiqui

Naseem

et al. 2013

Journal of Chemistry

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This review article recapitulates the analytical methods for the quantitative determinations of diltiazem and three H2receptor antagonists (cimetidine, ranitidine, and famotidine) by one of the spectroscopic technique (UV spectrophotometery) and separation technique such as high-performance liquid chromatography (HPLC). The clinical and pharmaceutical analysis of these drugs requires effective analytical procedures for quality control, pharmaceutical dosage formulations, and biological fluids. An extensive survey of the literature published in various analytical and pharmaceutical chemistry-related journals has been compiled in its review. A synopsis of reported spectrophotometric and high-performance liquid chromatographic methods for individual drug is integrated. This appraisal illustrates that majority of the HPLC methods reviewed are based on the quantitative analysis of drugs in biological fluids, and they are appropriate for therapeutic drug monitoring purpose.

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High-Performance Liquid Chromatography Method for Assay of Diltiazem Hydrochloride and Its Related Compounds in Bulk Drug and Finished Tablets

Cited by 15 publications

References 10 publications

Validated gradient stability indicating HPLC method for determining Diltiazem Hydrochloride and related substances in bulk drug and novel tablet formulation

Validated gradient stability indicating HPLC method for determining Diltiazem Hydrochloride and related substances in bulk drug and novel tablet formulation

Indirect spectrophotometric determination of diltiazem hydrochloride in pure form and pharmaceutical formulations

An Overview of Analytical Determination of Diltiazem, Cimetidine, Ranitidine, and Famotidine by UV Spectrophotometry and HPLC Technique

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