Friday , 27 November 2020

Analytical Method Development and Validation for the Simultaneous Estimation of Alogliptin and Pioglitazone by Using RP-HPLC

H. Pranusha1, Dr. Gampa Vijay Kumar2*
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A  B  S  T  R A C T
A new method was established for simultaneous estimation of Alogliptin and Pioglitazone by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Alogliptin and Pioglitazone by using Thermosil C18 column (4.0×125mm) 5µ, flow rate was 0.7 ml/min, mobile phase ratio was (70:30 v/v) methanol: Sodium acetate bufferpH 3(pH was adjusted with orthophosphoricacid), detection wavelength was 252nm. The instrument used is (Shimadzu HPLC Auto Sampler, Separation model; number SPD20A, LC Solutois) (photodiode array detector 996) the retention times were found to be 2.566 mins and 3.417mins. The % purity of Alogliptin and Pioglitazone was found to be 97.89% and 100.03% respectively. The system suitability parameters for Alogliptin and Pioglitazone such as theoretical plates and tailing factor were found to be 4668, 1.3 and 6089 and 1.2, the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Alogliptin and Pioglitazone was found in concentration range of 50µg-250µg and 5µg-25µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.55% and 99.47%, %RSD for repeatability was 0.86 and 0.82, % RSD for intermediate precision was 0.44 and 0.19 respectively. The precision study was precise, robust, and repeatable.LOD value was 3.17 and 5.68, and LOQ value was 0.0172 and 0.2125 respectively.
Keywords: Thermosil C18 column, Alogliptin and Pioglitazone, RP-HPLC, Methanol.

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