Abstract

DEVELOPMENT AND VALIDATION OF NOVEL ANALYTICAL HPLC METHOD FOR TIGECYCLINE

Ashwini Muluk*, Yogita Adhav, Rupali Shinde and Aishwarya Shinde

ABSTRACT

A selective and simple HPLC method was developed for tigecycline from bulk, which was operated on C18 column with 20mM Diammonium hydrogen phosphate (pH-7.9) (80%) and Acetonitrile (20%) solutions at a flow rate of 1.0 mL/min. Tigecycline was detected at 9.4 min retention time, at 248 nm wavelength. The correlation coefficient (R2) for tigecycline was 0.9981 in 25-150 μg/mL respectively. System precision studies were performed by injecting six repeated injections of 100% concentration of standard solution. Precision for tigecycline was found to be 0.26 % RSD. For accuracy, sample solutions were analysed in triplicate at 25%, 75%, and 150%and the accuracy of tigecycline was found in the ranged of 98.7 to 99.8 %. For LOD signal to noise ratio of approximately 3:1 and for LOQ 10:1 ratio is taken. This method was validated with respect to linearity, precision, limit of detection and limit of quantitation. The results of the validation studies show that the HPLC method is sensitive, accurate and precise.

Keywords: Tigecycline, HPLC, Method development, Validation.