Additional file 1 of Stability indicating high performance thin layer chromatography method development and validation for quantitative determination of tetracycline hydrochloride in tetracycline hydrochloride active pharmaceutical ingredient (API) and its dosage forms
Creators: name: Gashaw, Misganaw
name: Layloff, Thomas
name: Hymete, Ariaya
name: Ashenef, Ayenew
Publisher: name: figshare
Year: 2024
Subjects: subject: Biochemistry
subject: Space Science
subject: Medicine
subject: Cell Biology
subject: Genetics
subject: FOS: Biological sciences
subject: Biotechnology
subject: Chemical Sciences not elsewhere classified
subject: Developmental Biology

description: Additional file 1: Table S1. Standards and samples of TC-HCl with its impurities standards. Table S2. Mobile phase composition setting for robustness investigation corresponding to low (-), central (0) and high (+) level using fractional factorial design. Table S3. Different factors setting for robustness investigation corresponding to low (-), central (0) and high (+) level using fractional factorial design. Figure S1. Band of TC-HCl (0.26), EATC (0.274), ETC (0.11) and ATC (0.40) with ethyl acetate: acetonitrile: methanol: 1% ammonium solution (4.4:19.6:10:6 (V/V)) at 366nm of TLC visualizer II. Figure S2. Chromatogram of TC-HCl, 4-EATC, ETC and ATC observed under TLC visualizer II at 366 nm with optimised solvent system. Figure S3. Peaks for developed chromatograms with optimized mobile phase at 366nm under TLC Visualizer 2. Figure S4. UV spectrum of tetracycline HCl on scanning in the wave-length range of 260-410 nm. Figure S5. Bands of TC-HCl and products of its forced degradation with optimized mobile phase at 366 nm under TLC visualizer. Figure S6. Peaks for standard TC-HCl (1) and TC-HCl under stress conditions (0.1M NaOH (2), heated (3) and exposed to 254 nm (4)) for forced degradation study. Figure S7. Calibration curve of Tetracycline HCl using HPTLC method. Table S4. Execution of the fractional factorial experimental design for mobile phase composition and its responses to study robustness of the proposed HPTLC method. Table S5. Execution of the fractional factorial experimental design for different factors and its responses to study robustness of the proposed HPTLC method. Figure S8. 3D surface plot showing MP composition change effect on response of HPTLC method (peak area (1) &amp; Rf value (2)) tetracycline HCl. Figure S9. 3D surface plot for effect of change of different factors on response of HPTLC method (peak area (1) &amp; Rf (2)). Table S6. ANOVA analysis results for fractional factorial model of mobile phase composition change effect on HPTLC method responses. Table S7. ANOVA analysis results for fractional factorial model for different factors change effect on HPTLC responses. Figure S10. Peak of tetracycline HCl API and eye ointment pharmaceutical products with HPTLC method. Figure S11. Peak of TC-HCl working standard and skin ointment pharmaceutical products with HPTLC method. Figure S12. Peak of mixture of TC-HCl and 4-EATC (A) and TC- HCl WS using official HPLC method. Figure S13. Peak of TC-HCl skin ointment with official HPLC method. Figure S14. Peak of TC-HCl API and eye ointment with official HPLC method. Figure S15. Peak of TC-HCl eye ointment with USP HPLC method. Figure S16. Peak for tetracycline HCl (Rf, 0.30±0.02) with semi-automated HPTLC without background noise correction (A) and with background noise correction (B). Figure S17. Degradation of tetracycline HCl in 0.1M HCl at environmental TO (1), 0.1M HCl at 80Oc for 2hrs (2), 0.1M NaOH at environmental TO (3), 0.1M NaOH at 80Oc for 2hrs (4), 3% H2O2 solution (5) and standard solution (6). Table S8. Peak area of 400 ng/band TC-HCl in stress conditions using semi-automated HPTLC. Figure 18. Calibration curve of tetracycline HCl for semi-automated HPTLC. Table S9. Calibration parameters obtained from the semi-automated HPTLC method. Figure 19. Pareto charts of rank (X-axis) vs t-value of |effect| (Y-axis) showing the effect of MP composition change (1) and change of other factors (2) on responses of semi-automated HPTLC. Table S11. MP composition change effect on robustness of HPTLC-1 method with FFD. Table S12. Testing of robustness of factors change for semi-automated HPTLC method full factorial design. Figure S20. Perturbation plot for peak area response (1A&amp;2A) RF response (1B&amp;2B) for effect of factors on responses HPTLC-1 method. Table S13. Statistical Parameters from ANOVA for semi-automated HPTLC. Figure S21. 3D surface plot showing effect of MP composition and different factors on HPTLC-1 response (1and 3–peak area. And 2 and 4–RF-value). Table S14. Stability study of 200 ng/band sample solution with semi-automated HPTLC method.