RP-LC simultaneous quantitation of co-administered drugs for (non-insulin dependent) diabetic mellitus induced dyslipidemia in active pharmaceutical ingredient, pharmaceutical formulations and human serum with UV-detector

Arayne, M. Saeed; Sultana, Najma; Tabassum, Arman

doi:10.1016/j.cca.2013.06.020

Cited by 11 publications

(9 citation statements)

References 25 publications

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“…These all were quite exclusive methods because of their extended and monotonous pretreatment of the samples, extraction with solvent and derivatization for the analysis of pregabalin. Our research group has reported a number of LC methods for the determination of various drugs as quinolones [13][14][15], cephalosporines [16], Ca channel blockers [17], ACE inhibitors [18][19][20][21] and antidiabetic drugs [22][23][24][25][26][27]. In continuation with this work we report are rapid, sensitive, selective, precise, short time analysis and cost effective RP-HPLC method for the quantitation of pragabalin in API, dosage formulations and human serum, the method is being validated according to ICH guidelines [28,29].…”

Section: Introductionmentioning

confidence: 99%

Monitoring of Pregabalin in Pharmaceutical Formulations and Human Serum Using UV and RP-HPLC Techniques: Application to Dissolution Test Method

M¹

2014

Pharm Anal Acta

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Section: Introductionmentioning

confidence: 99%

Monitoring of Pregabalin in Pharmaceutical Formulations and Human Serum Using UV and RP-HPLC Techniques: Application to Dissolution Test Method

M¹

2014

Pharm Anal Acta

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“…We observed two reasons for the absence of validation data in the articles: the study was performed before the guidelines had been published [53][54][55][56][57][58][59][60][61][62][63][64][65][66]; and the study focus was on method development and validation was not addressed [67][68][69][70][71][72]. Other reasons for excluding articles were: non-simultaneous method [74][75][76][77], inappropriate sample preparation [78,79], literature review [80], animal plasma sample [81], language in non-Roman characters [82][83][84], validation of only one analyte [85,86], and pharmacokinetic studies (PK) that used a previously developed and validated method [87][88][89][90][91][92][93][94][95][96][97].…”

Section: Systematic Literature Searchmentioning

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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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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“…Therefore, high selectivity and sensitivity analytical method is needed. Various methods using HPLC and LC-MS/MS have been expands for the simultaneous quantification of metformin and glimepiride in plasma matrices [11][12][13][14][15][16][17][18][19]. HPLC is one of the selected methods for analysis in this study, it is widely used for pharmaceutical analysis or bioanalysis and available in almost all analytical chemistry laboratories [20].…”

Section: Introductionmentioning

confidence: 99%

The Optimization of Rp-HPLC Condition Using Response Surface Methodology Box-Behnken Design for Simultaneous Determination of Metformin HCL and Glimepiride in Spiked Plasma

Izma¹,

Martono²,

Lukitaningsih³

2019

Int J App Pharm

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Objective: Aim of this study was to develop and validate the RP-HPLC method using Box-Behnken Design (BBD) for simultaneous analysis metformin HCl and glimepiride in spiked plasma. Methods: The chromatographic system was comprised of acetonitrile-phosphate buffer 0.0125 M+Sodium Dodecyl Sulphate (SDS) 1 mmol as a mobile phase and Ascentis® Phenyl C18 (250 x 4.6 mm i.d.; 5 µm) column as a stationary phase with UV detector at 210 nm. Three independent variables included phosphate buffer (%), pH and flow rate were optimized using Box-Behnken Design. The observed responses were retention time, peak area and resolution. Results: The predicted optimum condition of the RP-HPLC system consisted of phosphate buffer solution of 72%, pH at 4.3 and flow rate at 0.8 ml/min. By using this condition, the duration of analysis was more than 18 min, so it was necessary to modify the flow rate to be 1.0 ml/min to get shorter analysis duration. This condition was then applied to analyze metformin and glimepiride in spiked plasma and validated according to the EMA guideline. AUC of interfering components at the IS retention time between 588-1092 mV, the linearity of metformin was 0.9993 and glimepiride was 0.9991, accuracy and precision were between-13.33% until 16.08%, dilution integrity and metformin stability studies were between-4.01% until 11.82%, and for glimepiride stability studies were between-37.48% until-4.76%. Conclusion: Box-Behnken Design can help optimize the HPLC system, and the optimum condition was valid to analyze metformin and glimepiride in spiked plasma by considering the storage time of plasma samples.

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RP-LC simultaneous quantitation of co-administered drugs for (non-insulin dependent) diabetic mellitus induced dyslipidemia in active pharmaceutical ingredient, pharmaceutical formulations and human serum with UV-detector

Cited by 11 publications

References 25 publications

Monitoring of Pregabalin in Pharmaceutical Formulations and Human Serum Using UV and RP-HPLC Techniques: Application to Dissolution Test Method

Monitoring of Pregabalin in Pharmaceutical Formulations and Human Serum Using UV and RP-HPLC Techniques: Application to Dissolution Test Method

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

The Optimization of Rp-HPLC Condition Using Response Surface Methodology Box-Behnken Design for Simultaneous Determination of Metformin HCL and Glimepiride in Spiked Plasma

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