Stability Indicating HPLC Determination of Tigecycine in Pharmaceutical Dosage Forms

Stability Indicating HPLC Determination of Tigecycine in Pharmaceutical Dosage Forms


Kurien J, Jayasekhar P


Abstract

A simple, selective, precise and stability indicating high performance liquid chromatographic (HPLC) method of analysis of Tigecycline in pharmaceutical dosage form was developed and validated. The chromatographic conditions comprised of a reversible phase C18 column (250 × 4.6 mm, 5µm ) with a mobile phase consisting of a mixture of acetonitrile and acetic acid (0.1% aqueous solution, pH:3.5) in the ratio of 20:80. Flow rate was 0.4ml/min. Detection was carried out at 250nm. The retention time of Tigecycline was 5.02 min. Tigecycline was subjected to acid and alkali hydrolysis, oxidation, photochemical and thermal degradation. The linear regression analysis data for the calibration plot showed good linear relationship in the concentration range of 50 – 150 µg/ml. The value of correlation coefficient, slope and intercept were 0.999, 145.9 and -1990 respectively. The method was validated for precision, accuracy, ruggedness and robustness. The drug undergoes degradation under acidic, basic, photochemical and thermal degradation conditions. All the peaks of degraded products were resolved from the active pharmaceutical ingredient with significant different retention times. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating one.


Keywords

RP-HPLC, Tigecycline, Stability indicating, Dosage forms, Validation


Cite This Article

Kurien J, Jayasekhar P, Stability Indicating HPLC Determination of Tigecycine in Pharmaceutical Dosage Forms, International Journal for Pharmaceutical Research Scholars, 2013, 2(4), 164-171.

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