Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF TIGECYCLINE AND ITS RELATED IMPURITIES

Aakisetti Siva Sankar* and G. Srinivasa Rao

ABSTRACT

For Tigecycline-related substances, an accurate, sensitive, and quick gradient reverse phase high performance liquid chromatography (RP-HPLC) method has been created and verified. The Phenomenex Luna C18 (150 x 4.6mm, 3) was subjected to HPLC analysis under circumstances where the column temperature was kept at 30°C. With the help of a mobile phase gradient programme and a flow rate of 0.8 mL/min, chromatographic separation was accomplished. There was a 25 l injection amount. 248 nm was the UV detection frequency. According to the ICH recommendations, the method's suitability was evaluated for specificity, linearity, accuracy, precision, limit of quantification, and limit of detection. Each impurity's limit of detection is less than 0.06% w/w, demonstrating the developed method's great sensitivity. Within the dosage range of 0.28 g/mL to 1.44 g/mL, the calibration curve was discovered to be linear. The calibration curve regression data displays a strong linear connection. Each impurity has a correlation coefficient (r2) that is higher than 0.999. This study's article provides detailed experiment findings.

Keywords: Tigecycline, Impurities, Forced degradation, HPLC analysis, Method justification.