Amlodipine bioequivalence study: quantification by liquid chromatography coupled to tandem mass spectrometry

Carvalho, Márcia; Oliveira, Celso Henrique de; Mendes, Gustavo Duarte; Sucupira, Maria Cláudia Araripe; Moraes, Maria Elisabete Amaral de; Nucci, Gilberto De

doi:10.1002/bdd.282

Cited by 47 publications

(42 citation statements)

References 7 publications

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“…HPLC [9][10][11] and LC-MS [12][13][14] for its determination in plasma/serum; HPLC 15) for its determination in human serum and pharmaceutical formulations; HPLC 16,17) ; HPTLC 18) for its determination in pharmaceuticals. Similarly, survey of literature for AML revealed methods based on spectrophotometry, 19) RP-HPLC 20) using fluorescence detection, HPLC-tandem mass spectrometry, 21,22) RP-HPLC using UV detection, 23,24) HPLC [25][26][27][28][29] in combination with other drugs, Flow injection analysis using UV-detection, 30) HPTLC, 31,32) stability indicating HPLC 33) and stability indicating HPLC 34) in combination with benazepril hydrochloride have been reported. Spectrophotometric 35) and HPLC 36) methods have been reported for simultaneous determination of ATV and AML, but these methods lack stability indicating nature.…”

Section: Atorvastatinmentioning

confidence: 99%

Stability Indicating RP-HPLC Method for Simultaneous Determination of Atorvastatin and Amlodipine from Their Combination Drug Products

2007

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Atorvastatin 1) is a synthetic lipid lowering agent which inhibits HMG-CoA reductase and amlodipine 2) is a calcium antagonist drug effective in hypertension and angina pectoris. The combination drug product of atorvastatin (ATV) and amlodipine (AML) has recently been introduced in the market; co-administration of AML with ATV demonstrated statistically significant dose-related reductions in systolic blood pressure (SBP), diastolic blood pressure (DBP) and LDL-C in patients with co-morbid hypertension and dyslipidemia. 3)Chemically ATV is [R-(R*,R*)]-2-(4-fluorophenyl)-b, dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2 : 1) trihydrate 4) and AML is 2-[(2-Aminoethoxy)-methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester. 5)Stability testing forms an important part of the process of drug product development. The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and enables recommendation of storage conditions, retest periods, and shelf lives to be established. The two main aspects of drug product that play an important role in shelf life determination are assay of active drug, and degradation products generated, during the stability study. The assay of drug product in stability test sample needs to be determined using stability indicating method, as recommended by the International Conference on Harmonization (ICH) guidelines 6) and USP-26. 7) Although stability indicating methods have been reported for assay of various drugs in drug products, most of them describe assay procedures for drug products containing only one active drug substance. Only few stability indicating methods are reported for assay of combination drug products containing two or more active drug substances. The objective of this work was to develop a simple, precise and rapid analytical LC procedure, which would serve as stability indicating assay method for combination drug product of ATV and AML.Both methods have been reported for simultaneous determination of ATV and AML, but these methods lack stability indicating nature. None of the reported analytical procedures describe a stability indicating method for simultaneous determination of ATV and AML in presence of their degradation products. This manuscript describes the development and validation of a stability indicating isocratic reversed-phase HPLC method for simultaneous determination of ATV and AML in presence of their degradation products as per ICH guidelines. The study describes development and subsequent validation of a stability indicating reverse-phase HPLC method for the simultaneous estimation of atorvastatin (ATV), and amlodipine (AML) from their combination drug product. The proposed RP-HPLC method utilizes a Lichrospher ® 100 C 18 , 5 m mm, 250 mm؋4.0 mm i.d. column, at ambient temperature, optimum ...

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Section: Atorvastatinmentioning

confidence: 99%

Stability Indicating RP-HPLC Method for Simultaneous Determination of Atorvastatin and Amlodipine from Their Combination Drug Products

2007

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“…The determination of amlodipine level in biological samples has been reported with high performance liquid chromatography with ultraviolet (HPLC-UV) [6][7][8][9] , and mass spectrometric detector [10][11][12][13][14] . Although several methods have been reported for the determination of amlodipine in plasma, these methods have low sensitivity and narrow range of linearity [10][11][12][13][14] .…”

Section: Introductionmentioning

confidence: 99%

“…Although several methods have been reported for the determination of amlodipine in plasma, these methods have low sensitivity and narrow range of linearity [10][11][12][13][14] . These are important parameters, especially when the determination is performed in clinical samples retrieved from subjects who took the drug at low dose.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Liquid Chromatography - Tandem Mass Spectrometry Method for Determination of Amlodipine in Human Plasma and Its Application

Pongnarin¹,

Thanakosai²,

Kingkhangphloo³

et al. 2017

Pharm Sci Asia

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A sensitive liquid chromatography tandem mass spectrometry method was developed to quantify amlodipine in human plasma. Alkalinized plasma spiked with desipramine, an internal standard, was extracted by liquid-liquid extraction and evaporated an organic part to dryness. The residue was reconstituted and injected into an Acquity Ultra Performance LC TM , (Waters, Co., Ltd. USA) with C 18 column. The isocratic elution of mobile phase was performed by 90% of acetonitrile and 10% of 10 mM ammonium acetate pH 4 at flow rate of 0.20 mL/min with 5 minutes of total run time. Mass spectrometric analysis was performed using a Quattro Premier XE mass spectrometer, (Micromass Technologies, UK) coupled with an electrospray ionization (ESI) source in the positive ion mode. The MRM transitions of m/z 409.17>238.19 and 409.17>294.09 were selected for amlodipine and 267.09>208.06 for desipramine. The retention times were 1.63 and 1.69 minutes for amlodipine and desipramine, respectively. The linearity of the method revealed a correlation coefficient of >0.998 within the concentration range of 0.05 -20 ng/mL. This work has been fully validated according to the Guidance for Industry: Bioanalytical Method Validation (USFDA CDER, 2001, BP) with high degree of accuracy and precision. This method was applied to quantify amlodipine concentrations in human plasma samples in a bioequivalence study.

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“…GC method was also proposed following trimethylacetyl derivatization in human plasma as matrix using ECD [15]. GC-MS, HPLC, spectroscopic methods are also reported for drug substance and AMB pharmaceutical formulation (tablets) [16][17][18][19][20][21][22]. Films for oral drug delivery most recently were made official in the European Pharmacopoeia, edition 7.4 and subordinated to the monograph 'oromucosal preparations' [23].…”

Section: Introductionmentioning

confidence: 99%

Development and Application of Rp-Hplc Method for Dissolution Study of Oral Formulations Containing Amlodipine Besylate

Pawar¹,

Yadav²

2015

Pharm Anal Acta

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In the present analytical study a rapid, robust and specific reversed-phase HPLC method has been developed and validated for quantitative estimation of amlodipine besylate in the dissolution study of oral films by direct injections of aqueous solutions. The study involved isocratic elution of amlodipine besylate in Zorbax ® Eclipse XDB-C18 analytical column using buffer (0.7 % aqueous triethylamine adjusted to pH 3.0 with orthophosphoric acid) and methanol in the ratio of 40:60 (v/v). The aqueous solutions were analysed at a flow rate of 1.0 ml/min at 239 nm. The method presented linearity (r 2 = 0.999) in the concentration range 20-150 µg/ml. The result indicated good recoveries ranging from 98.06% to 99.22%. The method showed good precision with % Relative standard deviation value less than 2. All the validation parameters were within the acceptance range. The developed method can be successfully employed for in-vitro dissolution and routine analysis of formulations containing Amlodipine besylate.

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Amlodipine bioequivalence study: quantification by liquid chromatography coupled to tandem mass spectrometry

Abstract: Since the 90% CI for AUC(last), AUC(0-inf) and C(max) ratios were within in the 80-125% interval proposed by the US FDA, it was concluded that Amlodipine 5 mg tablet (test formulation) was bioequivalent to Norvasc 5 mg tablet, in terms of both rate and extent of absorption.

Cited by 47 publications

References 7 publications

Stability Indicating RP-HPLC Method for Simultaneous Determination of Atorvastatin and Amlodipine from Their Combination Drug Products

Stability Indicating RP-HPLC Method for Simultaneous Determination of Atorvastatin and Amlodipine from Their Combination Drug Products

Development and Validation of Liquid Chromatography - Tandem Mass Spectrometry Method for Determination of Amlodipine in Human Plasma and Its Application

Development and Application of Rp-Hplc Method for Dissolution Study of Oral Formulations Containing Amlodipine Besylate

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