ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF AMIKACIN IN PURE AND MARKETED FORMULATION USING HPLCAbstract
The aim of the study was to develop an easy, sensible and rapid method for the estimation of amikacin in both pure and marketed formulation by pre derivatisation technique using reverse phase C18 column in HPLC. In this RP-HPLC method Shimadzu LC 20 AD of PDA detector was used with LC solutions software. In this method gradient elution with a mobile phase of acetonitrile and acetate buffer in the ratio of 25:75 v/v at the flow rate of 2 mL/min and run time of 10 min were used. Validation parameters of HPLC were found at detection wavelength of 272 nm. Linearity was observed with a concentration range of 10 – 50 µg/mL with R2 = 0.99. The method was robust with wavelength 271 and 273 nm with a flow rate of 1.8 and 2.2 mL/min showed good results. The retention time of drug was found at 8.9 min and assay showed 98.1%. RP-HPLC method was validated as per ICH guidelines and can be used for routine quantitative analysis of amikacin by RP-HPLC using PDA detector in both pure and marketed formulation. All the results of linearity, accuracy, precision were within the limits. The proposed method was highly sensitive, reproducible and reliable.
G. S. Teja, B. M. Gurupadayya * and K. V. Sairam
Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.
05 February, 2018
20 April, 2018
13 May, 2018
01 October, 2018