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

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.

Central composite design driven optimization of sustainable stability indicating HPLC method for the determination of Tigecycline and greenness assessment

“…9,10 TGC was previously determined using spectrophotometric methods, 11 fluorescence determination, [12][13][14] and liquid chromatography coupled with ultraviolet and mass spectrometry detection in human plasma [15][16][17][18][19][20][21][22][23][24][25][26] and pharmaceutical preparations. [27][28][29][30][31][32] Other methods, such as stability-indicating, [33][34][35][36][37][38][39] have also been used to determine the drug's parenteral dosage form. The bulk of these processes take significant time, are harmful to the surrounding ecosystem, and require using acetonitrile as a mobile phase.…”