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.
Highlights
Tigecycline is the first drug clinically available under the class of Glycylcyclines which are a new class of antibiotics derived from tetracycline
Tigecycline is a new glycylcycline with broad spectrum antibiotic activity
Tigecycline pure drug was obtained as gift sample from Gland Pharma Hyderabad, India
Summary
Tigecycline is the first drug clinically available under the class of Glycylcyclines which are a new class of antibiotics derived from tetracycline. Tigecycline inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and interfering with the entry of amino-acyl tRNA molecules into the A site of the ribosome. This blocks incorporation of amino acid residues into elongating peptide chains, thereby preventing protein synthesis and eventually bacterial cell growth. Glycylcyclines appear to bind more effectively compared to tetracyclines It has activity against a broad range of Gram-positive and Gram-negative bacteria, including tetracycline-resistant organisms. This tetracycline analogue overcomes tetracycline resistance by two mechanisms namely resistance mediated by acquired efflux pumps and ribosomal protection. The present research work describes the development and validation of a simple, rapid, accurate and precise RP-HPLC [4-13] method for estimation of Tigecycline in bulk and pharmaceutical formulation
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