Table Info

Table 5.

Interday precision and method precision studies of PMB

Drug	Concentration (μg/mL)	Day 1		Day 2		Day 3
Drug	Concentration (μg/mL)	Peak area (n = 3)	RSD (%)	Peak area (n = 3)	RSD (%)	Peak area (n = 3)	RSD (%)
PMB	5	2,892	0.856	2,921	0.977	2,864	0.918
	10	12,027	0.838	11,850	0.843	11,800	0.856
	15	24,487	0.981	24,649	0.922	24,599	0.991
	20	39,297	0.890	39,504	0.878	39,512	0.870
	25	50,486	0.711	50,507	0.863	50,328	0.970
Mean	-	-	0.855	-	0.896	-	0.921
Overall RSD (%)							0.890

-: blank cell

Supplementary materials

The supplementary material for this article is available at: https://www.explorationpub.com/uploads/Article/file/10082_sup_1.pdf.

Declarations

Author contributions

DS: Conceptualization, Investigation, Writing—original draft. TC: Conceptualization, Investigation, Writing—original draft. BDK: Validation, Writing—review & editing, Supervision.

Conflicts of interest

The authors declared that they have no conflict of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

References

Budhavant SU, Shinde KC, Sable AR, Pawar SD. A review: introduction and over view study on pharmaceutuical process of validation. World J Pharm Res. 2020;9;640–62.

Thapar S, Chawla A, Gupta GK. A concise review on method development and validation parameters. GSC Biol Pharm Sci. 2022;19:66–77. [DOI]

Willard HH, Merritt LL Jr, Dean JA, Settle FA Jr. Instrumental methods of analysis, 7th edition. United States: Wadsworth Publishing Company; 1988.

Matuszewski BK, Constanzer ML, Chavez-Eng CM. Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC − MS/MS. Anal Chem. 2003;75:3019–30. [DOI] [PubMed]

Burgess C. Valid analytical methods and procedures: a best practice approach to method selection. Royal Society of Chemistry; 2000. [DOI]

Ermer J. Validation in pharmaceutical analysis. Part I: an integrated approach. J Pharm Biomed Anal. 2001;24:755–67. [DOI] [PubMed]

Huber L, George SA. Diode array detection in HPLC. Chemistry; 1993.

ich.org [Internet]. Geneva: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; c2022 [cited 2022 May 3]. Available from: https://www.ich.org

Gautam CS, Saha L. Fixed dose drug combinations (FDCs): rational or irrational: a view point. Br J Clin Pharmacol. 2008;65:795–6. [DOI] [PubMed] [PMC]

10.

Fletouris DJ, Psomas JE, Botsoglou NA. Trace analysis of oxytetracycline and tetracycline in milk by high-performance liquid chromatography. J Agric Food Chem. 1990;38:1913–7. [DOI]

11.

Dihuidi K, Kucharski MJ, Roets E, Hoogmartens J, Vanderhaeghe H. Quantitative analysis of doxycycline and related substances by high-performance liquid chromatography. J Chromatogr A. 1985;325:413–24. [DOI]

12.

Levy SB. Antibiotic use for growth promotion in animals: ecologic and public health consequences. J Food Prot. 1987;50:616–20. [DOI] [PubMed]

13.

Kurittu J, Lönnberg S, Virta M, Karp M. Qualitative detection of tetracycline residues in milk with a luminescence-based microbial method: the effect of milk composition and assay performance in relation to an immunoassay and a microbial inhibition assay. J Food Prot. 2000;63:953–7. [DOI] [PubMed]

14.

Furusawa N. Rapid liquid chromatographic determination of oxytetracycline in milk. J Chromatogr A. 1999;839:247–51. [DOI] [PubMed]

15.

De Wasch K, Okerman L, De Brabander H, Van Hoof J, Croubels S, De Backer P. Detection of residues of tetracycline antibiotics in pork and chicken meat: correlation between results of screening and confirmatory tests. Analyst. 1998;123:2737–41. [DOI] [PubMed]

16.

Gamal M, Naguib IA, Abdelfatah RM. Simultaneous analysis of oxytetracycline hydrochloride, lidocaine, and bromhexine hydrochloride in the presence of many interfering excipients. Arch Pharm (Weinheim). 2021;354:e2100131. [DOI] [PubMed]

17.

Sokol J, Matisova E. Determination of tetracycline antibiotics in animal tissues of food-producing animals by high-performance liquid chromatography using solid-phase extraction. J Chromatogr A. 1994;669:75–80. [DOI] [PubMed]

18.

Temboot P, Kaewpaiboon S, Tinpun K, Nakpeng T, Khalil R, Ul-Haq Z, et al. Potential of sodium deoxycholate sulfate as a carrier for polymyxin B: physicochemical properties, bioactivity and in vitro safety. J Drug Deliv Sci Technol. 2020;58:101779. [DOI]

19.

Cao G, Ali FE, Chiu F, Zavascki AP, Nation RL, Li J. Development and validation of a reversed-phase high-performance liquid chromatography assay for polymyxin B in human plasma. J Antimicrob Chemother. 2008;62:1009–14. [DOI] [PubMed]

20.

Oka H, Ikai Y, Ito Y, Hayakawa J, Harada KI, Suzuki M, et al. Improvement of chemical analysis of antibiotics. XXIII. Identification of residual tetracyclines in bovine tissues by electrospray high- performance liquid chromatography–tandem mass spectrometry. J Chromatogr B Biomed Sci Appl. 1997;693:337–44. [DOI] [PubMed]

21.

Cinquina AL, Longo F, Anastasi G, Giannetti L, Cozzani R. Validation of a high-performance liquid chromatography method for the determination of oxytetracycline, tetracycline, chlortetracycline and doxycycline in bovine milk and muscle. J Chromatogr A. 2003;987:227–33. [DOI] [PubMed]

22.

Hede K. Antibiotic resistance: an infectious arms race. Nature. 2014;509:S2–3. [DOI] [PubMed]

23.

Kaale E, Chambuso M, Kitwala J. Analysis of residual oxytetracycline in fresh milk using polymer reversed-phase column. Food Chem. 2008;107:1289–93. [DOI]

24.

Falagas ME, Kasiakou SK. Toxicity of polymyxins: a systematic review of the evidence from old and recent studies. Crit Care. 2006;10:R27. [DOI] [PubMed] [PMC]

25.

Carr C Jr, Morrison DC. Mechanism of polymyxin B-mediated lysis of lipopolysaccharide-treated erythrocytes. Infect Immun. 1985;49:84–9. [DOI] [PubMed] [PMC]

26.

Gai Z, Samodelov SL, Kullak-Ublick GA, Visentin M. Molecular mechanisms of colistin-induced nephrotoxicity. Molecules. 2019;24:653. [DOI] [PubMed] [PMC]