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RP-HPLC Method for Simultaneous Determination of Pioglitazone and Telmisartan in Tablet Dosage Form


Affiliations
1 Dept. of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, Komara Palayam-638183, Tamil Nadu, India
2 Department of Pharmaceutical Chemistry, Ultra College of Pharmacy, Madurai-625020, Tamil Nadu, India
     

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A Simple and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative determination of Diacerein in bulk and its pharmaceutical formulations. Chromatographic separation was performed by using column XDB C8 (4.6×150 mm, 5 μm) with a mobile phase comprising of a mixture of phosphate buffer and Acetonitrile (50:50,v/v) and pH adjusted to 3 with orthophosphoric acid, at a flow rate of 0.8 ml/min with detection at 254 nm. Separation was completed in less than 10 min. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of quantitation, limit of detection, ruggedness and robustness. Linearity of Diacerein was found to be in the range of 10-100 μg/ml and correlation coefficient was found to be 0.999. The retention time of Diacerein was 3.3 min;the separation was performed at an ambient temperature. The limit of Detection and limit of quantitation for Diacerein was found to be 3.6 and 9.95 (S/N ratio). There was no significant difference in the intraday and inter day analysis of Diacerein determined for five different concentrations using this method. The RSD value 0.3% indicates a high precision of the analytical method.

Keywords

The Proposed Method was Simple, Sensitive, Precise, Accurate and Useful for Routine Quality Control Analysis.
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  • RP-HPLC Method for Simultaneous Determination of Pioglitazone and Telmisartan in Tablet Dosage Form

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Authors

P. Kalai Selvi
Dept. of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, Komara Palayam-638183, Tamil Nadu, India
T. Venkatachalam
Dept. of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, Komara Palayam-638183, Tamil Nadu, India
V. Kishor Kumar
Dept. of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, Komara Palayam-638183, Tamil Nadu, India
K. G. Lalitha
Department of Pharmaceutical Chemistry, Ultra College of Pharmacy, Madurai-625020, Tamil Nadu, India

Abstract


A Simple and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative determination of Diacerein in bulk and its pharmaceutical formulations. Chromatographic separation was performed by using column XDB C8 (4.6×150 mm, 5 μm) with a mobile phase comprising of a mixture of phosphate buffer and Acetonitrile (50:50,v/v) and pH adjusted to 3 with orthophosphoric acid, at a flow rate of 0.8 ml/min with detection at 254 nm. Separation was completed in less than 10 min. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of quantitation, limit of detection, ruggedness and robustness. Linearity of Diacerein was found to be in the range of 10-100 μg/ml and correlation coefficient was found to be 0.999. The retention time of Diacerein was 3.3 min;the separation was performed at an ambient temperature. The limit of Detection and limit of quantitation for Diacerein was found to be 3.6 and 9.95 (S/N ratio). There was no significant difference in the intraday and inter day analysis of Diacerein determined for five different concentrations using this method. The RSD value 0.3% indicates a high precision of the analytical method.

Keywords


The Proposed Method was Simple, Sensitive, Precise, Accurate and Useful for Routine Quality Control Analysis.