Thursday , 21 March 2019

Analytical Method Development and Validation for the Simultaneous Estimation of Empagliflozin and Linagliptin In Pharmaceutical Dosage Forms By RP-HPLC Method

Dr.K.Nageswara Rao1*, Raghava Doonaboyina2, S.Rajesh3
1Professor and Head, Dept. of Pharmaceutical Analysis, K.G.R.L College  of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.
2Associate Professor and Head, Dept. of Pharmaceutical Chemistry, K.G.R.L College  of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.
3K.G.R.L College  of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.

A B S T R A C T
A new method was established for simultaneous estimation of Empagliflozin   and Linagliptin by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Empagliflozin and Linagliptin by using Agilent C1 85µm(4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer ph 4.0 : ACN  (30:70%v/v), detection wave length was 254nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector996, Empower-softwareversion-2. The retention times were found to be 3.503 mins and 2.577 mins. The % purity of Empagliflozin   and Linagliptin was found to be 100.3% and 101.1% respectively. The system suitability parameters for Empagliflozin   and Linagliptin such as theoretical plates and tailing factor were found to be 1.3, 5824.4 and 1.2,2936.0 the resolution was found to be 9.4. The analytical method was validated according to ICH guidelines (ICH,Q2(R1)). The linearity study for Empagliflozin   and Linagliptin was found  in  concentration  range   of  20μg-100μg  and  20μg-100μg   and correlation coefficient(r2)was foundtobe 0.999 and 0.999, %mean recovery was found to be 102.5% and 101.0%, % RSD for repeatability was 0.6 and 0.5, %RSD for intermediate precision was 0.7 and 0.6 respectively. The precision study was precise, robust,  and repeatable. LOD value was 3.1 and 3.02, and LOQ value was 10.1 and 10 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Empagliflozin   and Linagliptin in API and Pharmaceuticaldosage form.
Keywords: AgilentC18, Empagliflozin   and Linagliptin, RP-HPLC

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