Development and Validation of UV Spectroscopic Method for Estimation of Fosfomycin In Fosfomycin for Injection

American Journal of PharmTech Research

article

Gaurav D. Chaudhari¹  Shubham D. Patil¹  Hemant V. Chaudhari¹  Dipika G. Itnare¹  Pratiksha J. Patil¹  Kalpesh V. Sonar²  Parag R. Patil² 

[1] Department of Pharmacy, Shree Sant Muktabai Institute of Technology;Department of Pharmaceutical Analysis, KYDSCT’S College of Pharmacy

关键词: Fosfomycin;    UV Spectrophotometer;    Melting Point;    Assay Method;    Validation;    Accuracy;    Linearity;    Ruggedness;    Precision;   

DOI  :  10.46624/ajptr.2021.v11.i1.002

学科分类：药学

来源: American Journal Of Pharmtech Research

【 摘 要 】

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Fosfomycin in Fosfomycin for Injection. The drug is freely soluble in analytical grade water 1 . The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics 2 . It showed absorption maxima were determined in analytical grade water. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity 4, 5, 6. The UV spectroscopic method was developed for estimation of Fosfomycin in injection dosage form and also validated as per ICH guidelines. The drug is freely soluble in analytical grade water, slightly soluble in 95% Methanol and Ethanol. Almost insoluble in anhydrous acetone, ether and chlorinated solvent. So, the analytical grade water is used as a diluent in method. The melting point of Fosfomycin was found to be 94 - 95˚C (uncorrected). It showed absorption maxima 254 nm in analytical grade water. On the basis of absorption spectrum the working concentration was set on 50µg/ml (PPM). The linearity was observed between 30-70 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101.00 and 99.17% for three levels respectively. The % RSD for precision was found to be 0.41%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Fosfomycin in Fosfomycin for Injection dosage form. The method could be considered for the determination of Fosfomycin in quality control laboratories.

【 授权许可】

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