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Simultaneous Estimation of Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride in Pharmaceutical Dosage Forms by RP-HPLC Method


Affiliations
1 CRO, Veeda, Ahmedabad, India
2 Department of Pharmaceutical Analysis, Veerayatan Institute of Pharmacy, Kutch, India
3 Department of Pharmaceutical Sciences, Saurastra University, Rajkot, Gujarat, India
4 CVM Institute for Degree Course in Pharmacy, New Vallabh Vidhyanagar, India
5 Ipcowala Indukaka College of Pharmacy, Vallabh Vidhyanagar, India
     

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A simple, specific, accurate and stability indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of and Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride in tablet dosage forms. Detector consists of photodiode array detector; the reversed phase column used was RP-C18 (2.27 μm size, 250 mm´4.6 mm i.d.) at ambient temperature, in isocratic mode, with mobile phase containing Methnol: Acetonitrile: Phosphate Buffer, pH 5.39 (20: 40: 40% v/v/v) adjusted to pH 5.39 using ortho phosphoric acid was used. The flow rate was 1.0 ml/min and effluents were monitored at 238 nm. The retention times of Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride were 3.69 min, 8.18 min and 12.5 min respectively.

The calibration curves were linear in the concentration range of 4-24 μg/ml for Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride. The proposed method was validated and successfully applied to the estimation of Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride in combined tablet dosage forms. Linearity was obtained in the concentration range of 4 to 24 μg/ml of Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride with a correlation coefficient of 0.9963, 0.9992 and 0.9957 respectively. Detector consists of photodiode array detector; the reversed phase column used was RP-C18 (2.27 μm size, 250 mm, 4.6 mm i.d.) at ambient temperature. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method was successfully applied for simultaneous determination of Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride in routine analysis.

Keywords

Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride, RP-HPLC.
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  • Simultaneous Estimation of Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride in Pharmaceutical Dosage Forms by RP-HPLC Method

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Authors

Chetan Ramolia
CRO, Veeda, Ahmedabad, India
Zarna Dedania
Department of Pharmaceutical Analysis, Veerayatan Institute of Pharmacy, Kutch, India
Ronak Dedania
Department of Pharmaceutical Analysis, Veerayatan Institute of Pharmacy, Kutch, India
N. R. Sheth
Department of Pharmaceutical Sciences, Saurastra University, Rajkot, Gujarat, India
G. Vidya Sagar
Department of Pharmaceutical Analysis, Veerayatan Institute of Pharmacy, Kutch, India
Bhavna Patel
CVM Institute for Degree Course in Pharmacy, New Vallabh Vidhyanagar, India
K. K. Bhatt
Ipcowala Indukaka College of Pharmacy, Vallabh Vidhyanagar, India

Abstract


A simple, specific, accurate and stability indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of and Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride in tablet dosage forms. Detector consists of photodiode array detector; the reversed phase column used was RP-C18 (2.27 μm size, 250 mm´4.6 mm i.d.) at ambient temperature, in isocratic mode, with mobile phase containing Methnol: Acetonitrile: Phosphate Buffer, pH 5.39 (20: 40: 40% v/v/v) adjusted to pH 5.39 using ortho phosphoric acid was used. The flow rate was 1.0 ml/min and effluents were monitored at 238 nm. The retention times of Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride were 3.69 min, 8.18 min and 12.5 min respectively.

The calibration curves were linear in the concentration range of 4-24 μg/ml for Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride. The proposed method was validated and successfully applied to the estimation of Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride in combined tablet dosage forms. Linearity was obtained in the concentration range of 4 to 24 μg/ml of Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride with a correlation coefficient of 0.9963, 0.9992 and 0.9957 respectively. Detector consists of photodiode array detector; the reversed phase column used was RP-C18 (2.27 μm size, 250 mm, 4.6 mm i.d.) at ambient temperature. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method was successfully applied for simultaneous determination of Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride in routine analysis.

Keywords


Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride, RP-HPLC.