Development of a New Analytical Method for Determination of Related Components in Nateglinide

Madhavi, Alavala Siva; Reddy, G. Sampath Kumar; Suryanarayana, M.; Naidu, A.

doi:10.1365/s10337-008-0548-z

Cited by 5 publications

(4 citation statements)

References 13 publications

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“…5 The synergistic action of both drugs is beneficial in patients who are nonresponsive to traditional monotherapy and its coadministration does not affect the pharmacokinetic behavior of the individual drug. 6 The published studies described simultaneous estimation of nateglinide and metformin hydrochloride by UV, 7,8 HPTLC, 9,10 micellar liquid chromatography, 11 and HPLC [12][13][14][15][16] in pharmaceutical dosage forms. For biostudies, UP-HPLC, 17 RP-HPLC, 18 and LC-MS 19 are currently available for individual estimation of both drugs in human plasma, 20 rabbit plasma, 21,22 and rat plasma.…”

Section: Introductionmentioning

confidence: 99%

Design of experiment‐based LC‐MS/MS method development for simultaneous estimation of nateglinide and metformin hydrochloride in rat plasma

et al. 2021

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This research aims to develop and validate a bioanalytical method for simultaneous estimation of an antidiabetic combination using LC-MS/MS in rat plasma. Nateglinide and metformin hydrochloride are commonly used combination for clinical management of Type 2 diabetes. Hence, simultaneous determination in plasma is essential for the rapid analysis of samples from the pharmacokinetic studies. Statistical optimization was carried out for liquid chromatography (LC) parameters and mass spectroscopic (MS) parameters by design of experiment (DoE) (Design Expert Version 11, Stat Ease Inc., USA) approach. A 3 3 full factorial design was used for optimization of LC parameters; %methanol, %formic acid, and flow rate were selected as independent variables, whereas peak area and tailing factor were considered as dependent variables for both drugs. Box-Behnken design was used to optimize MS parameters including drying gas flow rate, nebulizing gas flow rate, DL temperature, heat block temperature, and positive voltage as independent factors, and responses selected were [M + H] + intensity of nateglinide and metformin hydrochloride. The [M + H] + intensity of the optimized method for nateglinide and metformin hydrochloride were 2,462,838 and 11,873,826, respectively. The model was found significant for optimizing LC and MS parameters with p < 0.05 for both nateglinide and metformin hydrochloride. The optimized method was validated as per the ICH-M10 guideline, which was accurate, precise, and selective. The method was cost-effective and capable of quantitating concentrations in picogram levels for nateglinide and metformin hydrochloride simultaneously.

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Section: Introductionmentioning

confidence: 99%

Design of experiment‐based LC‐MS/MS method development for simultaneous estimation of nateglinide and metformin hydrochloride in rat plasma

et al. 2021

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“…Nateglinide has been determined alone in pharmaceutical formulations by spectrophotometry (Jain et al, 2009), HPLC (Hacıoğlu et al, 2015) and UPLC (Xavier et al, 2012). It has also been determined simultaneously with its degradation products and impurities (Madhavi et al, 2008), with metformin and meglinides class of antidiabatetics (El-Zaher et al, 2018), fourteen synthetic antidiabetics (Cui et al, 2010) by UV detector and HPLC. Estimation of nateglinide in rabbit plasma (Sankalia et al, 2007), rat plasma (Dey et al, 2020) and urine (Lam et al, 2020) has been described.…”

Section: Introductionmentioning

confidence: 99%

“…Among these studies, significant peak tailing of nateglinide on stationary phases was reported. To overcome this problem, Cui et al reported the addition of sodium dodecyl sulfate and triethylamine in the mobile phase on a Diamonsil C18 column (Cui et al, 2010), El-Zaher et al presented the use of Lichorosper NH2 column and the tailing factor was given as 1.422 (El-Zaher et al, 2018), Madhavi et al used Zorbax C8 column and the tailing factor was given as 1.2 (Madhavi et al, 2008).…”

Section: Introductionmentioning

confidence: 99%

Determination of Nateglinide in Tablet Formulation by HPLC Using a Pentafluorophenyl Core-Shell Column

Yılmaz¹

2021

Iğdır Üniversitesi Fen Bilimleri Enstitüsü Dergisi

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Nateglinide is an insulin secretagogue which has been used for the treatment of Type 2 Diabetes mellitus. A simple analytical methodology for determination of nateglinide in tablet formulation is described. An isocratic reversed phase high performance liquid chromatographic (HPLC) method was developed using Kinetex pentafluorophenyl (PFP) (5µm particle size and 4.6 x 150 mm id) core-shell column as stationary phase and 0.05 M Na2HPO4 (pH=2.0) / methanol (30:70 v/v) mixture as mobile phase with the flow rate of 1.0 mL min -1 and diode-array detector at 215 nm. Column was termostated at 22°C. Under these conditions nateglinide was eluted with a symmetrical peak shape and the retention time was 4.779 minutes. The system suitability parameters such as tailing factor, capacity factor and theoretical plate were evaluted. The method was validated as per International Council on Harmonisation (ICH) guidelines. Linearity was obtained in the 2.54 -40.70 µg mL -1 concentration range with equation y= 10.818x + 4.7048 (R 2 = 0.998). Limit of detection and limit of quantification were 1.07 and 2.54 µg mL -1 . Accuracy of the method was tested by recovery studies which were in the range of 98.78 -100.76 %. The intra-day and inter-day precision studies were carried out and the relative standard deviation values of peak areas were within ICH limits. The proposed method was successfully applied to the determination of nateglinide in tablet dosage form.

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“…small millivolt full scale response). Other published methods used for pharmaceutical preparations have included capillary electrophoresis [15], chiral chromatography for the separation of tadalafil enantiomers [16], and tadalafil used as an internal standard for determining letrazole levels using fluorescence detection [17]. …”

Section: Introductionmentioning

confidence: 99%

A simple and sensitive HPLC fluorescence method for determination of tadalafil in mouse plasma

Farthing

Koka

et al. 2010

Journal of Chromatography B

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A simple and sensitive high-performance liquid chromatographic (HPLC) method utilizing fluorescence detection was developed for the determination of the phosphodiesterase type 5 inhibitor tadalafil in mouse plasma. This method utilizes a simple sample preparation (protein precipitation) with high recovery of tadalafil (∼98%), which eliminates the need for an internal standard. For constituent separation, the method utilized a monolithic C 18 column and a flow rate of 1.0 ml/min with a mobile phase gradient consisting of aqueous trifluoroacetic acid (0.1% TFA in deionized water pH 2.2, v/v) and acetonitrile. The method calibration was linear for tadalafil in mouse plasma from 100 to 2000 ng/mL (r > 0.999) with a detection limit of approximately 40 ng/ mL. Component fluorescence detection was achieved using an excitation wavelength of 275 nm with monitoring of the emission wavelength at 335 nm. The intra-and inter-day precision (relative standard deviation, RSD) values for tadalafil in mouse plasma were less than 14%, and the accuracy (percent error) was within -14% of the nominal concentration. The method was utilized on mouse plasma samples from research evaluating the potential cardioprotective effects of tadalafil on mouse heart tissue exposed to doxorubicin, a chemotherapeutic drug with reported cardiotoxic effects.

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Development of a New Analytical Method for Determination of Related Components in Nateglinide

Cited by 5 publications

References 13 publications

Design of experiment‐based LC‐MS/MS method development for simultaneous estimation of nateglinide and metformin hydrochloride in rat plasma

Design of experiment‐based LC‐MS/MS method development for simultaneous estimation of nateglinide and metformin hydrochloride in rat plasma

Determination of Nateglinide in Tablet Formulation by HPLC Using a Pentafluorophenyl Core-Shell Column

A simple and sensitive HPLC fluorescence method for determination of tadalafil in mouse plasma

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