SIMULTANEOUS DETERMINATION OF TIGECYCLINE AND ITS POTENTIAL IMPURITIES BY A STABILITY-INDICATING RP-HPLC-UV DETECTION TECHNIQUE

V. N. V. KISHORE; G. V. RAMANA

doi:10.22159/ijap.2022v14i1.41243

Authors

V. N. V. KISHORE Department of Chemistry, AG and SGS College, Vuyyuru 521165, India
G. V. RAMANA Department of Chemistry, Andhra Loyola College, Vijayawada 520008, A. P., India

DOI:

https://doi.org/10.22159/ijap.2022v14i1.41243

Keywords:

Tigecycline, Impurities, Forced degradation, HPLC analysis, Method justification

Abstract

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: 10 mmol 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 231 nm as wavelength, high-pitched peaks of Tigecycline (Tig) and its impurities (1and2) were detected at 6.55, 8.73 and 4.87 min correspondingly. The linearity of tigecycline and its impurities (impurity-1 and 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 originated to be (1.37,0.047 and 0.071 µg/ml) and (4.15, 0.143 and 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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