Method Development and Validation of Metformin, Glimepiride and Pioglitazone in Tablet Dosage Form by Rp-HPLC

Suchitra, M; Sunitha, D.; Parthiban, C.; Siddartha, B.; Madhavi, C.

doi:10.7897/2230-8407.04850

Cited by 7 publications

(1 citation statement)

References 6 publications

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“…It is a thiazolidine Dione derivative and chemically (RS)-5-(4-[2-(5-ethylpyridin-2-yl) ethoxy] benzyl) thiazolidine-2, 4-dione. HPLC and UV-visible spectrophotometry methods have been reported for its individual determination of Pioglitazone and in combination with other drugs [8][9][10][11][12][13][14][15] . As per the literature, various methods are available for the estimation of these three drugs individually or in combination of two drugs in a pharmaceutical dosage form and also from biological samples.…”

Section: Introductionmentioning

confidence: 99%

A New and Rapid Analytical Method Development and Validation for Simultaneous Estimation of Metformin, Pioglitazone and Glimepride in Tablet Dosage Form by Using Uplc

Reddy¹,

Kumar²,

Kumar³

2014

Int. Res. J. Pharm.

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The present work was undertaken with the aim to develop and validate a rapid and consistent UPLC method in which the peaks will be appear with short period of time as per ICH Guidelines. The proposed method was simple, fast, accurate and precise method for the Quantification of drug in the dosage form, bulk drug as well as for routine analysis in Quality control. UPLC method was developed and validated for simultaneous estimation of Metformin, Pioglitazone and Glimepiride in bulk drug and in combined dosage forms. The UPLC separation was achieved on a Symmetry C18 (2.1 x 100 mm, 1.7 mm, Make: BEH) or equivalent in an Isocratic Mode. The mobile phase was composed of Phosphate Buffer (25 %) whose pH was adjusted to 4.3 by using Ortho Phosphoric Acid and Methanol (75 %) [UPLC Grade] The flow rate was monitored at 0.25 ml per min. The wavelength was selected for the detection was 258 nm. The run time was 5 minutes. The retention time found for the drugs Metformin, Pioglitazone and Glimepiride were 0.002 minutes, 1.773 minutes and 2.409 minutes respectively. The % recovery was found to be 99.7 %-100.9 % for the drug Metformin. The % recovery was found to be 98.4 %-100.9 % for the drug Pioglitazone. The % recovery was found to be 99.9 %-101.2 % for the drug Glimepiride. The linearity was established in the range of 400 to 600 ppm for the drug Metformin and 12 to18 ppm for the drug Pioglitazone and 0.8 to 1.2 ppm for the drug Glimepiride. The LOD for the drugs Metformin, Pioglitazone and Glimepiride were found to be 0.12 µg/ml, 0.002 µg/ml and 0.002 µg/ml respectively. The LOQ for the drugs Metformin, Pioglitazone and Glimepiride were found to be 0.45 µg/ml, 0.15 µg/ml and 0.08 µg/ml respectively. The proposed method was adequate sensitive, reproducible, and specific for the determination of Metformin, Pioglitazone and Glimepiride in bulk as well as in Tablet dosage form. The validation of method was carried out utilizing ICH-guidelines. The described UPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. Overall the proposed method was found to be suitable and accurate for the Quantitative determination of the drug in Tablet dosage form. The method was simple, precise, accurate and sensitive and applicable for the simultaneous determination of Metformin, Pioglitazone and Glimepiride in bulk drug and in combined dosage forms.

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Section: Introductionmentioning

confidence: 99%

A New and Rapid Analytical Method Development and Validation for Simultaneous Estimation of Metformin, Pioglitazone and Glimepride in Tablet Dosage Form by Using Uplc

Reddy¹,

Kumar²,

Kumar³

2014

Int. Res. J. Pharm.

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Application of a Fast Separation Method for Anti-diabetics in Pharmaceuticals Using Monolithic Column: Comparative Study With Silica Based C-18 Particle Packed Column

Hemdan

Abdelaziz

2018

Journal of Chromatographic Science

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Run time is a predominant factor in HPLC for quality control laboratories especially if there is large number of samples have to be analyzed. Working at high flow rates cannot be attained with silica based particle packed column due to elevated backpressure issues. The use of monolithic column as an alternative to traditional C-18 column was tested for fast separation of pharmaceuticals, where the results were very competitive. The performance comparison of both columns was tested for separation of anti-diabetic combination containing Metformin, Pioglitazone and Glimepiride using Gliclazide as an internal standard. Working at high flow rates with less significant backpressure was obtained with the monolithic column where the run time was reduced from 6 min in traditional column to only 1 min in monolithic column with accepted resolution. The structure of the monolith contains many pores which can adapt the high flow rate of the mobile phase. Moreover, peak symmetry and equilibration time were more efficient with monolithic column.

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Eco-friendly HPLC method by using response surface design to measure a combination of three antidiabetic drugs

Al-Tannak,

Hemdan

2023

Reviews in Analytical Chemistry

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In recent years, there has been a significant increase in the application of green chemistry principles in analytical chemistry. One of the key factors affecting the environmental sustainability of analytical methods is the choice of solvent. In this particular study, a two-factor, three-level response surface design was employed to develop an environmentally friendly chromatographic technique for a mixture of metformin, glimepiride, and pioglitazone. Ethanol, which is known to be harmless to the environment, was chosen as the organic modifier in the mobile phase. The separation of the mixture was achieved using a phosphate buffer solution (pH 3) mixed with ethanol (30:70 v/v). The linearity of the developed method covered a concentration of metformin of 10–120 µg·mL−1 with a correlation coefficient of 0.9998, glimepiride of 0.1–20 µg·mL−1 with a correlation coefficient of 0.9997, and pioglitazone of 1–50 µg·mL−1 with a correlation coefficient of 0.9999. To evaluate the environmental friendliness of the developed method, two assessment tools were employed: The Analytical GREEnness metric and Green Analytical Procedure Index. The results revealed that the developed method performed exceptionally well in terms of its eco-friendliness. Furthermore, the developed method was compared to other reported methods in terms of both accuracy and environmental sustainability. The results demonstrated that the developed method serves as an excellent alternative to well-established techniques for the separation and quantification of the analyzed mixture. Overall, this study highlights the importance of integrating green chemistry principles into analytical chemistry practices.

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Method Development and Validation of Metformin, Glimepiride and Pioglitazone in Tablet Dosage Form by Rp-HPLC

Cited by 7 publications

References 6 publications

A New and Rapid Analytical Method Development and Validation for Simultaneous Estimation of Metformin, Pioglitazone and Glimepride in Tablet Dosage Form by Using Uplc

A New and Rapid Analytical Method Development and Validation for Simultaneous Estimation of Metformin, Pioglitazone and Glimepride in Tablet Dosage Form by Using Uplc

Application of a Fast Separation Method for Anti-diabetics in Pharmaceuticals Using Monolithic Column: Comparative Study With Silica Based C-18 Particle Packed Column

Eco-friendly HPLC method by using response surface design to measure a combination of three antidiabetic drugs

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