Monday , 18 March 2019

Analytical Method Development and Validation for the Simultaneous Estimation of Trimetazidine & Propranolol in Combination by RP-HPLC

Dr. G. Uma soundarya1, Kondapu Ramya2
1Asst. Professor, Nova College of Pharmaceutical  Education & Research, Jupudi Village, Ibrahimpatnam, Krishna, Vijayawada, Andhra Pradesh, India.
2Nova College of Pharmaceutical Education & Research, Jupudi Village, Ibrahimpatnam, Krishna, Vijayawada, Andhra Pradesh, India.

A B S T R A C T
A new method was established for simultaneous estimation of Trimetazidine and Propranolol by RP-HPLC method. The chromatographic conditions were success fully developed for the separation of Trimetazidine and Propranolol by using Thermosil C18 column (4.0×125mm) 5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: Sodium acetate buffer pH 3 (pH was adjusted with orthophosphoricacid), detection wavelength was 252nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2690, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.566 mins and 3.417 mins. The % purity of Trimetazidine and Propranolol was found to be 101.27% and 99.97% respectively. The system suitability parameters for Trimetazidine and Propranolol 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 Trimetazidine and Propranolol was found in concentration range of 5µg-25µg and 50µg-250µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %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. Hence the suggested RP-HPLC
Keywords: Thermosil C18 column, Trimetazidine and Propranolol, RP-HPLC.

Scroll To Top