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Research Article Open access CC BY 4.0

RP-HPLC Method Development and Validation for Determination of Tigecycline in Bulk and Pharmaceutical Dosage form

K. Bhavyasri, C. H. Mounika, Narmada Vallakeerthi, M. Sumakanth

Journal of Pharmaceutical Research International · pp. 273–282 · Published 3 Aug 2021

10.9734/jpri/2021/v33i39B32204

Abstract

Aims: To develop and validate a new, simple, rapid, precise and accurate Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for the quantitative determination of Tigecycline in bulk and pharmaceutical dosage form. Study Design: Place and Duration of the Study: RBVRR women's college of pharmacy, Barkatpura, Hyderabad, between june 2019 and july 2020. Methodology: The RP-HPLC method was developed on Sunsil C18 150 mm x 4.6mm x 5µ column using acetonitrile : water (pH maintained at 3.5 with acetic acid) [70:30] as mobile phase at flow rate 0.8 ml/min and UV detection at 250 nm. Results: Tigecycline exhibited linearity over the concentration range of 5-40 µg/mL (R2 > 0.999). The analytical method showed good precision with % RSD below 2. The method showed suitable accuracy and robustness. Conclusion: Validation of the developed method was done as per International Conference on Harmonization (ICH) Q2R1 guidelines.

Reverse Phase High Performance Liquid Chromatography Tigecycline method development Validation International Conference on Harmonization (ICH) Q2R1

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