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Abstract

A NEW RP – HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HCL AND LINAGLIPTIN IN TABLET DOSAGE FORM

Dnyaneshwar Thakare*1, Patil Vikas1, Kalkotwar Ramesh1, Jadhav Vijay b1, Chandra K Sekhar2

1 Department of Quality Assurance, SND College of Pharmacy, Pune University, Yeola Dist, Nasik, India.
2Richer Pharmaceuticals, Prasanthinagar, Kukatpally, Hyderabad, India.

ABSTRACT

A new simple accurate and suitable reverse phase high performance liquid chromatographic method was developed for the determination of Metformin and Linagliptin in bulk and tablet dosage form. The separation was eluted on a Zodiac C18 column (250 mm x 4.6 mm; 5μ) using a mobile phase mixture of mixed phosphate buffer 6.5 and acetonitrile in a ratio of 50:50 v/v at a flow rate of 1.0ml/min. The detection was made at 248 nm. The retention times were 2.08±0.1min for Metformin and 5.73±0.1min for Linagliptin. Calibration curve was linear over the concentration range of 125-750μg/ml for Metformin and 0.625 - 3.750 μg/ml for Linagliptin. The propose method was validated as per the ICH guidelines parameters like Linearity, specificity, precision, accuracy, robustness and ruggedness. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.

Keywords: Method development and validation, Linagliptin, Tablets, C18 column, RPHPLC


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