Determination of Amlodipine in Pharmaceutical Dosage Forms by Liquid Chromatography and Ultraviolet Spectrophotometry

Malesuik, Marcelo Donadel; Cardoso, Simone Gonçalves; Bajerski, Lisiane; Lanzanova, Fibele Analine

doi:10.1093/jaoac/89.2.359

Cited by 30 publications

(16 citation statements)

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“…Selectivity of the developed method was assessed by performing forced degradation studies [9][10][11][12][13]. According to ICH [14] stress testing of the drug substance can help the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedure used. Photo stability testing should be an integral part of stress testing.…”

Section: Selectivity/specificitymentioning

confidence: 99%

“…The literature survey reveals that several methods were reported for the individual estimation of Amlodipine and Benazepril. Various methods using HPLC [5][6][7], RP-HPLC [8,9], HPTLC [10,11], LC-MS [12], LCMS/MS [13] and simultaneous UV spectrophotometric methods [14,15] are reported for the estimation of Amlodipine alone or Benazepril alone or in combination with other agents [16]. In USP, the reported analytical procedures describe a method for simultaneous determination of Amlodipine and Benazepril in combined pharmaceutical dosage form in the presence of their degradants with 110 minutes as runtime.…”

Section: Introductionmentioning

confidence: 99%

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New Stability Indicating Method for Quantification of Impurities in Amlodipine and Benazepril Capsules by Validated HPLC

Eranki¹,

Inti²,

Jayaraman³

et al. 2013

AJAC

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A stability indicating LC method was developed for the simultaneous determination of Amlodipine and Benazepril capsules in pharmaceutical dosage form. Efficient chromatographic separation was achieved on Symmetry C 18 stationary phase with simple combination of amobile phase containing 750 mL of DI Water, 250 mL of Acetonitrile and 2 mL of Octylamine into suitable container with adjusted pH to 2.50 ± 0.05 with the aid of Ortho phosphoric acid delivered in an isocratic mode and quantification was carried out using UV detection at 240 nm at a flow rate of 1.0 mL•min −1 with an injection volume of 20 μl and ambient column temperature. This method is capable to detect both the drug components of Amlodipine and Benazepril in presence of their degradation products (Amlodipine Imp-A and Benazepril Impurity-C) with a detection level of 0.05%. Amlodipine/Benazepril in their combination drug product were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the samples were analysed. Peak homogeneity data of Amlodipine and Benazeprilis were obtained using PDA detector, in the stressed sample chromatograms, demonstrating the specificity. The method shows excellent linearity over a range of 0.05%-2.0% for Amlodipine, Amlodipine Impurity-A and 0.05%-5.0% for Benazepril and Benazepril Impurity-C. The correlation coefficient for Amlodipine and Benazepril is 1. The relative standard deviation was always less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and the stability study of Amlodipine and Benazepril in pharmaceutical preparations. The developed HPLC method was validated with respect to linearity & range, accuracy, precision and robustness.

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Section: Selectivity/specificitymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

New Stability Indicating Method for Quantification of Impurities in Amlodipine and Benazepril Capsules by Validated HPLC

Eranki¹,

Inti²,

Jayaraman³

et al. 2013

AJAC

View full text Add to dashboard Cite

show abstract

“…Methods [13,14] are reported for the estimation of amlodipine alone or in combination with other antihypertensive agents. Methods such as HPLC [15][16][17], LC-MS [18][19][20], protein precipitation [21], capillary electrophoresis [22], and simultaneous UV spectrophotometer methods [23,24] are reported for estimation of valsartan alone or in combination with other agents.…”

Section: Introductionmentioning

confidence: 99%

New Stability Indicating Method for Quantification of Impurities in Amlodipine and Valsartan Tablets by Validated HPLC

Eranki

Inti²,

Jayaraman³

et al. 2013

ISRN Medicinal Chemistry

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A stability indicating LC method was developed for simultaneous determination of amlodipine and valsartan in pharmaceutical dosage form. Efficient chromatographic separation was achieved on C8 stationary phase with simple combination of mobile phase-A (70 : 20 : 10 v/v/v of water : acetonitrile : methanol with 2 mL of Octylamine adjusted the pH to 2.50 + 0.05 with orthophosphoric acid) and mobile phase-B (Acetonitrile) delivered in gradient mode. Quantification was carried out using ultraviolet detection at 240 nm at flow rate of 1.0 mL/min with Injection Volume of 100 μL and ambient column temperature. This method was capable to detect both the drug components of Amlodipine and Valsartan in presence of their degradation products (Amlodipine Imp-A and Valsartan Impurity-B) with the detection level of 0.05%. Amlodipine/Valsartan and their combination drug product were exposed to thermal studies, photolytic, hydrolytic and oxidative stress conditions, and samples analysed. Peak homogeneity data of Amlodipine and Valsartan is obtained using PDA detector, demonstrating the specificity. The method shows excellent linearity over range of 0.05–2.0% for Amlodipine; Amlodipine Impurity-A and 0.05–1.0% for Valsartan and Valsartan Impurity-B. The correlation coefficient for Amlodipine and Valsartan are 0.9999. The proposed method was found to be suitable and accurate for quantitative determination and the stability study of Amlodipine and Valsartan in pharmaceutical preparations.

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“…Determination of AM was described in British pharmacopoeia [3] by HPLC method. It was also determined by several methods involving spectrophotometric methods [4][5][6][7][8][9][10][11], HPLC [9,[12][13][14][15] and Densitometric TLC method [16]. While VL was determined by several methods, involving spectrophotometric [17][18][19], HPLC [20][21][22][23][24][25] and chemometric methods [26].…”

Section: Introductionmentioning

confidence: 99%

Potentiometric Determination of Amlodipine Besilate and Valsartan Using Microsized and Polymeric Matrix Membrane Sensors

Ramadan

Mohamed

Mostafa

2012

Port. Electrochim. Acta

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Two poly(vinyl chloride) matrix membrane electrodes responsive to some drugs affecting the cardiovascular system, Amlodipine besilate (AM) and Valsartan (VL), were developed, described and characterized. A microsized graphite selective sensor was investigated with dibutylsebacate (DBS) as a plasticizer in a polymeric matrix of carboxylated polyvinyl chloride (PVC-COOH) in case of (sensor 1). This sensor 1 was prepared using 2-hydroxy propyl β-cyclodextrin (2HP β-CD) as an ionophore. While sensor 2 preparation was based on precipitation technique with bathophenanthroline iron (II) as electroactive materials in poly(vinyl chloride) (PVC) matrix. Fast and stable Nernstian responses near 1x10-5 -1x10 -3 M for the two drugs over the pH range 3-6 and 7-9 for the two sensors, respectively, were obtained. The method was successively applied for the determination of AM and VL in presence of each others, in their pharmaceutical formulations and in human plasma samples. The percentages recoveries for the determination of the drugs by the proposed selective electrodes were 99.78 ±0.382 %, 100.23 ± 0.440 %, for sensors 1 and 2, respectively. Statistical comparison between the results obtained by this method and those obtained by the official method and the reported method of the drugs was done and no significant difference was found.

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Determination of Amlodipine in Pharmaceutical Dosage Forms by Liquid Chromatography and Ultraviolet Spectrophotometry

Cited by 30 publications

References 0 publications

New Stability Indicating Method for Quantification of Impurities in Amlodipine and Benazepril Capsules by Validated HPLC

New Stability Indicating Method for Quantification of Impurities in Amlodipine and Benazepril Capsules by Validated HPLC

New Stability Indicating Method for Quantification of Impurities in Amlodipine and Valsartan Tablets by Validated HPLC

Potentiometric Determination of Amlodipine Besilate and Valsartan Using Microsized and Polymeric Matrix Membrane Sensors

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