SIMULTANEOUS DETERMANATION OF TIGECYCLINEAND ITS POTENTIALIMPURITIES BY A STABILITY INDICATING RP-HPLC - UV DETECTION TECHNIQUE
Keywords:Tigecycline, impurities, Forced Degradation, HPLC analysis, Method Justification
Objective: Stability representing the RP-HPLC method was established for synchronized quantification of Tigecycline and its impurities. This method was confirmed for its applicability to both tablet dosage and bulk drug forms.
Methods: Intended for an isocratic elution, a mobile phase containing methanol: 10mM Triethylamine Buffer mixture (75:25 v/v, pH 6.1) was used at 1 ml/min flow rate and Agilent ZORBAX Eclipse XDB C18 (250 mm × 4.6 mm, 5 μm) column.
Results: At 231nm as wavelength, high-pitched peaks of Tigecycline (Tig) and its impurities (1&2) were detected at 6.55, 8.73 and 4.87 min correspondingly. The linearity of tigecycline and its impurities (imp-1& 2 and) were estimated with ranging from 75 – 450 µg/mL for Tigecycline and 1–6 µg/mL for both impurity 1 and 2.The corresponding recognition limits (LOD and LOQ) of the tigecycline and its impurities were originate to be (1.37,0.047 & 0.071 µg/ml) and (4.15, 0.143 & 0.126 µg/ml).
Conclusion: The technique was effectively stretched for stability signifying studies under different stress conditions. Justification of the method was done as per the current ICH guidelines.
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