RP-HPLC Method Development and Validation for Determination of Tigecycline in Bulk and Pharmaceutical Dosage form
K. Bhavyasri *
Department of Pharmaceutical analysis, RBVRR Women's College of Pharmacy. Barkathpura, Hyderabad-500027, India.
C. H. Mounika
Department of Pharmaceutical analysis, RBVRR Women's College of Pharmacy. Barkathpura, Hyderabad-500027, India.
Narmada Vallakeerthi
Department of Pharmacy, University College of Technology, Osmania University, Hyderabad-500007, Telangana, India.
M. Sumakanth
Department of Pharmaceutical analysis, RBVRR Women's College of Pharmacy. Barkathpura, Hyderabad-500027, India.
*Author to whom correspondence should be addressed.
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.
Keywords: Reverse Phase High Performance Liquid Chromatography, Tigecycline, method development, Validation, International Conference on Harmonization (ICH) Q2R1