Rapid and simultaneous determination of nifedipine and dehydronifedipine in human plasma by liquid chromatography–tandem mass spectrometry: Application to a clinical herb–drug interaction study

Wang, Xueding; Li, Jiali; Lu, Yan; Chen, Xiao; Huang, Min; Chowbay, Balram; Zhou, Shu‐Feng

doi:10.1016/j.jchromb.2007.02.026

Cited by 57 publications

(40 citation statements)

References 48 publications

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“…High peak response and improved peak shape was found with Acetonitrile compared to methanol, used in mobile phase [14]. Moreover methanol in mobile phase likely affected stability of nifedipine in clinical sample analysis, probably due to nifedipine labile metabolite.…”

Section: Methods Developmentmentioning

confidence: 98%

“…These methods include HPLC [8][9][10][11][12][13][14] coupled with UV detectors or electrochemical detector, but tedious sample processing technique, lengthy analysis time and lack of sensitivity were major limitations in these methods. Diverse detection techniques like electron-capture detection [15][16][17][18][19][20], nitrogen phosphorus detection [21] and mass spectrometric (MS) detection [22,23] were reported.…”

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confidence: 99%

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Method Development Challenges and Regulatory Expectation in Nifedipine

Goswami

Gurule

Singh

et al. 2016

Int. J. Pharmacokinet.

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Aim: A novel and accurate high-throughput tandem mass spectroscopic method has been developed and validated for determination of nifedipine, a calcium-channel blocker. Materials & methods: Nifedipine was detected on a triple quadruple tandem mass spectrometer by multiple reactions monitoring mode via ESI source. Results: The selective and sensitive method was linear in the concentration range of 0.501 to 360.100 ng/ml and reported no matrix effect. The percent accuracy of the method was found to be between 99.7 and 102.80%, while percentage of RSD was in range of 1.77 to 4.73%. Conclusion: Validated method was used for bioavailability studies under fasting and fed conditions. Clinical pharmacokinetics of noncommunicable disease such as hypertension has interested the academicians and practitioners alike due to intricacies and limited knowledge of labile metabolites. Calciumchannel blocker drug slows down the progression of coronary artery calcification. Nifedipine (1,4-dihydro-2, 6-dimethyl-4-(2-nitrophenyl)-3,5-pyridine dicarboxylic acid dimethyl ester), belonging to the group of 1,4-dihydropyridines is one of the highly prescribed calcium-channel blockers that selectively dilates peripheral arteries [1]. It is widely used in the treatment of cardiovascular diseases such as hypertension, angina pectoris and Raynaud's phenomenon [2][3][4]. It inhibits the influx of extracellular calcium through myocardial and vascular membrane pores as well as restricts contractile processes of smooth muscle cells thereby decreasing total peripheral resistance and systemic blood pressure [5,6]. However, developing a robust method for analysis of Nifedipine in plasma is highly challenging due to multiple reasons. Nifedipine is a photo-labile compound, undergoing oxidative biotransformation in human body into pharmacologically inactive metabolites, dehydronifedipine and hydroxydehydro nifedipine carboxylate [7].In recent past, several analytical methods were reported for the determination of nifedipine in biological matrix. These methods include HPLC [8][9][10][11][12][13][14] coupled with UV detectors or electrochemical detector, but tedious sample processing technique, lengthy analysis time and lack of sensitivity were major limitations in these methods. Diverse detection techniques like electron-capture detection [15][16][17][18][19][20], nitrogen phosphorus detection [21] and mass spectrometric (MS) detection [22,23] were reported. However, scope of thermal decomposition of nifedipine under gas chromatography conditions was a co ncern and MS methods are usually preferred.Nifedipine is metabolized by cytochrome P-450 IIIA4 enzymatic activity, in vivo. Nifedipine metabolism involves oxidative dehydrogenation to dehydronifedipine, followed

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Section: Methods Developmentmentioning

confidence: 98%

mentioning

confidence: 99%

Method Development Challenges and Regulatory Expectation in Nifedipine

Goswami

Gurule

Singh

et al. 2016

Int. J. Pharmacokinet.

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“…The therapeutic importance and successful clinical uses of these drugs have promoted the development of many analytical methods for their determination in bulk, in their pharmaceutical formulations and in biological fluids. Analytical techniques such as; titrimetric methods [4,5], spectrometric methods (spectrophotometry [6][7][8][9][10][11][12][13] or spectrofluorimetry [13][14][15][16][17][18][19][20]), electrochemical methods [21][22][23], liquid chromatographic methods [24][25][26][27][28] and gas chromatographic methods [29][30][31][32] were reported for their determination.…”

Section: 4-dhp Drugs As Shown Inmentioning

confidence: 99%

A Novel Spectrophotometric Method for Determination of Five 1,4-Dihydropyridine Drugs in Their Tablets and Capsules Using Vanillin Reagent

Hamd¹,

Derayea²,

Abdelmageed³

et al. 2013

AJAC

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A selective and new spectrophotometric method is described for determination of five 1,4-dihydropyridine drugs (1,4-DHP); namely nifedipine (NIF), nicardipine (NIC), nimodipine (NIM), felodipine (FEL) and amlodipine (AML). The method is based on a coupling reaction between the cited drugs and vanillin reagent in acidic condition. Under optimized conditions, the red coloured products were measured at 500 nm for NIF, NIC, NIM and FEL or at 479 nm for AML. Molar absorptivities were ranged from 0.575 × 10 4 -1.065 × 10 4 l·mol, Beer's law was obeyed at 5 -70 µg/mL concentration range and the limit of detection was ranged from 0.150 -1.500 µg/mL. The proposed method was successfully extended to pharmaceutical preparations tablets and capsules and comparison by Student's t-test and variance ratio F-test showed no significant difference.

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“…Biologically, the selected model drug pine mechanism is bound L-type of Calcium Channel blocker (CCB s ) flux of cardiac and also smooth muscles with prominent specificity via affinity and inhibiting [3][4][5][6][7][8]. Literature, for CCB s plentiful techno and estimation methods were like Titrimetric [9,10], spectroscopic [11][12][13][14][15][16][17][18], Fluorimetric [19][20][21][22][23][24][25][26], electrochemical [27][28][29], Chromatographic methods [30][31][32][33][34][35][36][37][38] already reported [39][40][41][42]. Therefore, except a few anti-BP drugs till date there is no analytical quality design (QbD) stratagem.…”

Section: Introductionmentioning

confidence: 99%

Newfangled Quantitative Pharmacia (Isradipine) Stratagem: Quality by Design (Qbd) Taguchi Array via Response Surface (L25 Via CCD20) Methodology

Kharb¹

2015

Pharm Anal Acta

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Statistically (L 25 via CCD 20 ), a novel array via response surface analytical process was an attempt to develop a quantification of the pharmacies/bulk, Isradipine using organic medium (methanol & chloroform) as solvent. During analysis, the maximum absorption wavelength of model drug was found at lambda max 327nm and also done its recovery via validation further. In the beginning, by using a quality improvement statistically array looms (Taguchi) was generated numerous level/space (s) of the independent variable (A=methanol; B=chloroform & C=ratio of A: B) by performing experimentally (L 25 array runs to studied their response to be found the finer spaces). Additionally, a three-dimensional response surfaces strategy [RSM; three dimensional central composite designs (CCD 20 )] explored variables non-factorial levels which are used as fine. Also, responses quadratic (02 nd order) equation of response (Y=absorption) was predicted analytically for "finer to finest" (2.5 to 15μg/ml) by analysis alone variable space as well as together. Thus, newfangled Beer's finest in-terms of linearity, precision, sensitivity and accuracy during analysis range was found and also validated for further, finest determination. As well, economically inexpensive quantitative can be titled as newfangled analytical estimation of Isradpine (CCB s; Calcium channel blocker) in bulk/Pharmacia forms.

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Rapid and simultaneous determination of nifedipine and dehydronifedipine in human plasma by liquid chromatography–tandem mass spectrometry: Application to a clinical herb–drug interaction study

Cited by 57 publications

References 48 publications

Method Development Challenges and Regulatory Expectation in Nifedipine

Method Development Challenges and Regulatory Expectation in Nifedipine

A Novel Spectrophotometric Method for Determination of Five 1,4-Dihydropyridine Drugs in Their Tablets and Capsules Using Vanillin Reagent

Newfangled Quantitative Pharmacia (Isradipine) Stratagem: Quality by Design (Qbd) Taguchi Array via Response Surface (L25 Via CCD20) Methodology

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