Simultaneous Determination of Metformin in Combination with Rosiglitazone by Reversed-Phase Liquid Chromatography

Kolte, B. L.; Raut, B. B.; Deo, A. A.; Bagool, M. A.; Shinde, Devanand B.

doi:10.1093/chromsci/42.2.70

Cited by 46 publications

(16 citation statements)

References 8 publications

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“…The main reasons for excluding articles were that validation was performed in solution [41][42][43][44][45][46][47][48][49][50][51][52] and method development without validation [53][54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70][71][72]. Validation in solution with subsequent extrapolation to biological samples is not encouraged due to the matrix effect, a factor that should be considered when developing a bioanalytical method [3][4][5] and that will be further discussed in this review.…”

Section: Systematic Literature Searchmentioning

confidence: 99%

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A systematic and critical review on bioanalytical method validation using the example of simultaneous quantitation of antidiabetic agents in blood

Fachi

Leonart

Cerqueira

et al. 2017

Journal of Chromatography B

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A systematic and critical review was conducted on bioanalytical methods validated to quantify combinations of antidiabetic agents in human blood. The aim of this article was to verify how the validation process of bioanalytical methods is performed and the quality of the published records. The validation assays were evaluated according to international guidelines. The main problems in the validation process are pointed out and discussed to help researchers to choose methods that are truly reliable and can be successfully applied for their intended use. The combination of oral antidiabetic agents was chosen as these are some of the most studied drugs and several methods are present in the literature. Moreover, this article may be applied to the validation process of all bioanalytical.

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Section: Systematic Literature Searchmentioning

confidence: 99%

“…Twelve records were removed from this review because validation was performed in solution with the aim of applying the method to blood samples [41][42][43][44][45][46][47][48][49][50][51][52]. An example of this problem can be found in one of the included articles, from Magni et al [24].…”

Section: Matrix Effectmentioning

confidence: 99%

A systematic and critical review on bioanalytical method validation using the example of simultaneous quantitation of antidiabetic agents in blood

Fachi

Leonart

Cerqueira

et al. 2017

Journal of Chromatography B

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“…Rosiglitazone is an oral antidiabetic agent and acts as an agonist at PPAR gamma receptors have acts primarily enhances tissue sensitivity to insulin. A literature survey reveals that various analytical methods like rosiglitazone by HPLC and MECK 2 , Simple HPLC method for the determination of rosiglitazone in human plasma 3,4 , Simultaneous HPLC estimation of metformin in combination with rosiglitazone 5 ,rosiglitazone with gliclazide in tablet 6 , rosiglitazone and gemfibrozil in human plasma 7 . Simultaneous LC-UV estimation of rosigliazone and glimepiride in plasma 8 , rosigliazone and glimepiride in human plasma 9 .…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a Rp- HPLC Method for Estimation of Rosiglitazone in Bulk and Tablet Dosage Form

Singh¹,

Dwivedi

Kushnoor

2011

Int J of Adv in Phar Ana

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A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated of rosiglitazone in bulk and tablet dosage form. Chromatographic analysis was performed on a C 18 column (250x 4.6 mm, 5µm) with a mixture of Ammonium dihydrogen phosphate buffer (pH 4.5): Acetonitrilein the ratio 65:35 as mobile phase, at a flow rate of 1.0 mL min −1 . UV detection was performed at 230 nm. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The retention times of rosiglitazone was found to be 7.19±0.145 respectively. Linearity was obsered in concentration ranges of 12-70 µg mL −1 . The limit of detection was 0.725 and the quantification limit was 2.41 µg/ml. The accuracy of the proposed method was determined by recovery studies and found to be 98.26% to 101.37%. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to routine analysis of determination of rosiglitazone and in bulk and tablet dosage form.

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“…[2] However, the use of alternative modes of chromatographic separation may be more appropriate for the analysis of combination products. Many papers have been published describing the analysis of individual polar and moderately non-polar molecules using chromatographic methods such as reverse phase, [3][4][5] normal phase, [6,7] ion-pair, [8,9] ion exchange, [10,11] and hydrophilic interaction chromatography (HILIC). [12][13][14][15] HILIC, although not as well known or commonly used, has advantages over RP-HPLC in that both acidic and basic polar molecules can be retained.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Chromatographic Methods for Drug Products Containing Polar and Non-Polar Molecules Using Reversed Phase, Hydrophilic Interaction, and Ion Exchange Chromatography

Rogers

Crews

Long

et al. 2009

Journal of Liquid Chromatography & Related Technologies

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In recent years the pharmaceutical industry has developed an increasing variety of complex double or triple combination drug therapies. Method development for these combination drug products is particularly challenging when the analytes have significantly different polarities, often requiring multiple chromatographic methods for each active component. An alternative to the commonly used practice of developing multiple reversed phase chromatographic methods for analyzing small molecules in combination drug products is discussed herein.Ion exchange chromatography offers many advantages to other chromatographic techniques for the analysis of combination products if one of the molecules is highly polar (log P < 0) and the other moderately polar to non-polar (log P ! 0). As the primary mode of retention for ion exchange chromatography is based upon the charge of the molecule, the hydrophobicity of the molecule does not play as large of a part in the retention mechanism. As long as all of the molecules being analyzed are ionizable, retention on an ion exchange column should be possible. The analysis of polar and non-polar molecules simultaneously using ion exchange chromatography is a unique process, and the approach of developing accurate and robust analytical methods for analysis of all active pharmaceutical ingredients in a combination product by a single fast ion exchange method differs from the industry standard of using reverse phase methodology first.Six well characterized pharmaceuticals with varying degrees of polarity (metformin HCl, isoniazid, sodium nitroprusside, timolol maleate, naproxen sodium, and clonidine hydrochloride) have been chromatographically evaluated using RP, HILIC, and ion exchange chromatography. In addition, a well characterized pharmaceutical product, Metaglip TM Tablets, containing the highly polar molecule metformin HCl and the moderately non-polar glipizide, has been analyzed using a cation exchange (CE) HPLC method and compared to chromatography and results generated using RP-HPLC and hydrophilic interaction (HILIC)-HPLC.

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Simultaneous Determination of Metformin in Combination with Rosiglitazone by Reversed-Phase Liquid Chromatography

Cited by 46 publications

References 8 publications

A systematic and critical review on bioanalytical method validation using the example of simultaneous quantitation of antidiabetic agents in blood

A systematic and critical review on bioanalytical method validation using the example of simultaneous quantitation of antidiabetic agents in blood

Development and Validation of a Rp- HPLC Method for Estimation of Rosiglitazone in Bulk and Tablet Dosage Form

Evaluation of Chromatographic Methods for Drug Products Containing Polar and Non-Polar Molecules Using Reversed Phase, Hydrophilic Interaction, and Ion Exchange Chromatography

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