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Vol. 30 No. 12 (2018): Vol 30 Issue 12

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Chemometric Assisted Method Development for Teneligliptin and Metformin by Stability Indicating RP-HPLC Technique and its Validation

https://doi.org/10.14233/ajchem.2018.21561%20
Dasari Vasavi Devi
Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological University Anantapur, Anantapur-515 002, India
Dugasani Swarnalatha
Annamacharya College of Pharmacy, Rajampeta-516 126, India
Gopireddy Venkatasubba Reddy
Jawaharlal Nehru Technological University Anantapur College of Engineering, Pulivendula-516 390, India

Corresponding Author(s) : Dasari Vasavi Devi

dvas.reddy@gmail.com

Asian Journal of Chemistry, Vol. 30 No. 12 (2018): Vol 30 Issue 12

Abstract

An innovative quality by design approach is presented through the development of an RP-HPLC method for the analysis of antidiabetic drugs teneligliptin and metformin in its drug substance and drug products. Response surface optimization of the design experiments has been employed using quadratic central composite design (CCD) for the optimization of method parameters using reverse phase high-performance liquid chromatography (RP-HPLC) on Discovery C8, 250 × 4.6 mm, 5 m with UV detection at 261 nm. For the interaction and quadratic effects of three factors namely change in mobile phase ratio, flow rate and wavelength on the selected response using CCD model. This was applied to simultaneously optimize the retention time, peak area and tailing factor of teneligliptin and metformin. The predicted optimum assay condition consisted of buffer [0.1 % orthophosphoric acid (OPA) solution] and acetonitrile taken in the ratio 37:63 as mobile phase at a flow rate of 0.94 mL/min. Using this optimum condition, a retention time for metformin and teneligliptin were 3.086 min and 4.065 min, respectively have been achieved. After establishing the optimal conditions for separation, validation parameters like linearity, accuracy, precision, LOD, LOQ and robustness have been determined which were based on ICH Q2 guidelines. Hence, the proposed method can be used for quality control of teneligliptin and metformin in its tablet dosage forms.

Keywords

RP-HPLC Central composite design Teneligliptin Metformin
Devi, D. V., Swarnalatha, D., & Reddy, G. V. (2018). Chemometric Assisted Method Development for Teneligliptin and Metformin by Stability Indicating RP-HPLC Technique and its Validation. Asian Journal of Chemistry, 30(12), 2704–2710. https://doi.org/10.14233/ajchem.2018.21561
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