Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF GENTAMICIN SULPHATE

Ranveer Singh, Gurpreet Singh Sandhu*, Gursahib Singh Brar, Kamalpreet Singh

ABSTRACT

Gentamicin Sulphate in Injection (GB Gen 20mg) drug is used for the treatment of infections of the blood, central nervous system (such as meningitis), urinary tract, lungs, bones, joints, and the abdomen, such as the stomach, intestines, and other abdominal conditions including peritonitis. and other conditions. GB Gen 20mg injection may also be used for purposes not listed in this medication guide. To develop and validate a high performance liquid chromatographic method for the determination of Gentamicin Sulphate in Liquid dosage forms. A WATERS C18 column (50 mm × 4.6 mm, 5 μm) with mobile phase
consisting of Buffer (N- Heptane Sulphonic acid): MeOH: GAA (125:350:2.5) were used. The flow rate was 0.2 ml/ min and effluents were monitored at 330 nm. The retention time of Gentamicin Sulphate in Injection formulation were found to be 0.264 min. The method was validated according to the ICH guidelines for specificity, LOD, LOQ, precision, accuracy, linearity, ruggedness and robustness. For system suitability studies, six replicates of diluted Gentamycin sulphate standard g/mL of Gentamycin sulphate) were prepared and 10l solution was injected into the HPLC system. The mean peak area, % R.S.D. of peak area of six injections, peak asymmetry factor (at 10% peak height) number of theoretical plates, resolution and capacity factor were noted. The linearity standard solutions were prepared by diluting suitable quantity of Gentamycin sulphate stock solution in similar volumetric flasks with solvent. The linearity standard solutions were prepared at concentration of 8, 9, 10, 11 and 12 μg/mL for Gentamycin sulphate in triplicate. Gentamicin Sulphate R2= 1.108, Slope= 53173, Intercept= 54345, LOQ= 6.97 and LOD= 2.32.

Keywords: HPLC, Gentamicin sulphate, Method Development, Method Validation, ICH.