Pharmacokinetics Study of 1-ethyl-6-fluoro-1, 4-dihydro-4-oxo-7-[4-[(4-amino N-acetyl) phenoxy carbonyl methyl]-1-piperazinyl]-3-quinoline carboxylic acidusing spectrophotometric method
Iranian Journal of Pharmaceutical Sciences,
Vol. 21 No. 1 (2025),
21 January 2025
,
Page 32-47
https://doi.org/10.22037/ijps.v21i1.45493
Abstract
A spectrophotometric method was derived to determine 1-ethyl-6-fluoro-1, 4-dihydro-4-oxo-7-[4-[(4-amino N-acetyl) phenoxy carbonyl methyl]-1-piperazinyl]-3-quinoline carboxylic acid (PPQC). This analytical method was simple, sensitive and low-cost. Based on forming of a chelate complex between PPQC and Fe(III), the developed method produced a yellow-colored complex that was detectable at 418 nm at room temperature. As per the International Conference on Harmonization guidelines, several analytical parameters for the suggested method were verified. With a correlation coefficient of 0.9998 (n=6) and a molar extinction coefficient of 1.2967 × 104 L mol-1 cm-1, the method was linear from 5 to 46 µg mL-1. The limit of detection (LOD) and limit of quantitation (LOQ) for the described method were 0.69 µg mL-1 and 2.09 µg mL-1, respectively. It was carefully examined and optimized how different parameters affected the chelate complex reaction. The recoveries of PPQC from spiked blood samples were 98.40-100.40%. The developed method’s coefficient of variation (CV) was less than 2.07%. The method validation was determined in accuracy, precision, absolute recovery, freeze–thaw stability, bench-top stability and long-term stability. After oral administration of PPQC to Wistar albino rats, the method’s analytical recovery, sensitivity, and accuracy were adequate to characterize the pharmacokinetics study. Thus, pharmacokinetics data for pre-clinical research have been obtained efficiently through the assay method.
- Anhydrous Ferric Sulphate
- Biological fluid
- 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-[4-[(4-amino N-acetyl) phenoxy carbonyl methyl]-1-piperazinyl]-3-quinoline carboxylic acid
- Pharmacokinetics study
- Spectrophotometric method
How to Cite
References
Issa MM, Nejem RM, El-Abadla NS, Al-Kholy M, Saleh AA. Novel atomic absorption spectrometric and rapid spectrophotometric methods for the quantitation of paracetamol in saliva: application to pharmacokinetic studies. Indian journal of pharmaceutical sciences. 2008 May; 70(3):344-350
Behera S, Ghanty S, Ahmad F, Santra S, Banerjee S. UV-visible spectrophotometric method development and validation of assay of paracetamol tablet formulation. Int. J. Pharm. Sci. Res.(2012) 3 (12): 4945-4953.
Shah B, Patil P, Shah H. Chemical modification of paracetamol and their antimicrobial and pharmacological evaluation. Int. J. Pharm. Res. Bio-Sci. (2014) 3(2): 12-31.
Shah B, Patil P, Shah H. Synthesis, Pharmacological Activity and Spectrophotometric Determination of [Di (4-amino N-acetyl) phenoxy] methyl ketone in Biological Fluids. Int. J. Res. Pharm. Biomed. Sci.(2013) 4(4): 1038-1050.
Al-Swayeh OA, Futter LE, Clifford RH,Moore PK. Nitroparacetamol exhibits anti-inflammatory and anti- nociceptive activity. Br. J. Pharmacol.(2000) 130 (7): 1453-1456.
Profire L, Sunel V, Lupascu D, Baican MC, Bibire N, Vasile C. New Theophylline Derivatives with Potential Pharmacological Activity. Farmacia. (2010) 58(2): 170-176.
IwuozorKO. A Review on the Properties and Uses of Paracetamol. Int. J. Pharm. Chem.(2019) 5 (3): 31-35.
Farid NF, Abdelaleem EA. HPTLC method for the determination of paracetamol, pseudoephedrine and loratidine in tablets and human plasma. J. Chromatogr. Sci.(2016) 54 (4):647–652.
Ambekar A, KuchekarB. Application of a validated stability-indicating HPTLC method for simultaneous estimation of paracetamol and aceclofenac and their impurities. J. Chromatogr. Sep. Technol.(2016) 7 (3):324–334.
Belal T, Awad T, Clark R. Determination of paracetamol and tramadol hydrochloride in pharmaceutical mixture using HPLC and GC-MS. J. Chromatogr. Sci.(2009) 47 (10):849–854.
Sharma H, Vishakha K, Kumar KV, Bhatta HP. Validated RP-HPLC method for simultaneous estimation of paracetamol, pamabrom and dicyclomine, hydrochloride in bulk and pharmaceutical dosage form. Int. J. Pharm. Sci. Res.(2016) 7 (1):316–324.
Nazir A, Naseer Y, Shahid R, Raza S. Development & validation of analytical method used for simultaneous determination of paracetamol, caffeine and codeine phosphate by HPLC, in pharmaceutical formulation. Sci. Int.(2016) 28 (3):2497-2499.
Li H, Zhang C, Wang J, Jiang Y, Fawcett JP,Gu J. Simultaneous quantitation of paracetamol, caffeine, pseudoephedrine, chlorpheniramine and cloperastine in human plasma by liquid chromatography-tandem mass spectrometry. J. Pharm. Biomed. Anal.(2010) 51 (3):716–722.
Emre D, Özaltın N. Simultaneous determination of paracetamol, caffeine and propyphenazone in ternary mixtures by micellar electrokinetic capillary chromatography. J. Chromatogr. B Anal. Technol. Biomed. Life Sci.(2007) 847 (2):126–132.
Demirhan N, Tuncel Elmali F. Spectrophotometric Determination of Iron (II) with 5-Nitro-6-amino-1, 10-phenanthroline. Turk. J. Chem.(2003) 27(3): 315-321.
Topuz B, Adanur SM, Yalcuk A. A new method for simultaneous determination of trace amounts of Cu (II) and Ni (II) ions by preconcentration and spectrophotometric analysis. Turk. J. Chem.(2017) 41 (5): 619-629.
Quifen HU, Yang G, Dong X, Yin J. Study on the solid phase extraction andspectrophotometric determination of Cobalt with 2-(2-Quinolylazo)-5-Diethylaminoaniline. Turk. J. Chem. (2004) 28 (5): 611-619.
Soomro R, Ahmed MJ, Memon N. Simple and rapid spectrophotometric determination of trace level chromium using bis (salicylaldehyde) orthophenylene diamine in nonionicmicellar media. Turk. J. Chem. (2011) 35 (1): 155-170.
Belal S, Abdel-Razak O, El-Walily AF, Bakry R. Spectrophotometric determination ofCaptopril and Penicillamine through the use of ligand exchange complexation reactions. Int. J. Biomed. Sci. (2011) 7 (4): 289-294.
Bhardwaj N, Kaushik J.Spectrophotometric study of complexation of Labetalol withsome transition metal ions. World J. Pharm. Pharm. Sci.(2017) 6(3): 1108-1111.
Rajendraprasad N, Basavaiah K. Modified spectrophotometric methods fordetermination of Iron (III) in leaves and pharmaceuticals using salicylic acid. Indian J. Adv. Chem. Sci.(2016), 4(3):302-307.
Al-Nuzal SMD, Al-Oba YM, Al-Asadi AH. Analytical study of Al(III)-Tetracyclinecomplex for drug formulations. J. Appl. Chem.(2014) 3(4): 1592-1601.
El-Bagary RI, Elkady EF, Farid NA, Youssef NF. A Validated Spectrophotometric Method and Thermodynamic Studies for the Determination of Cilostazol and Rivaroxaban in Pharmaceutical Preparations Using Fe-Phenanthroline System. Anal. Chem. Lett.(2017) 7(5): 676-688.
Azmi SNH, Iqbal B, Jaboob MAM, Al Shahari WAS, Rahman N. Spectrophotometric Determination of Piroxicam via Chelation with Fe (III) in commercial Dosage Forms. J. Chin. Chem. Soc. (2009) 56 (6): 1083-1091.
Lutfullah, Sharma S, Rahman N, Azmi SNH, Hidaifi HJS, Alquasmi MMA.Spectrophotometric determination of Fe(III) via complexation with piroxicam in syntheticmixture and soil samples. J. Sci. Ind. Res.(2010) 69(2): 135-141.
Al-Hammoodi IAS, Al-Enizz MS, Saeed AM. A. Spectorphotometric Methods forDetermination of Terbutaline Sulfate in Pure and Pharamaceutical Formulation. J.Med. Chem. Sci.(2023) 6 (5): 1032-1043.
Salama F, El-Abasawy N, Razeq SA, Ismail MM, Fouad MM. Validation of the spectrophotometric determination of omeprazole and pantoprazole sodium via their metal chelates. Journal of pharmaceutical and biomedical analysis. 2003 Oct 15;33(3):411-421.
Gaber M, Khedr AM., El-Kady A. S. Spectrophtometric determination of norfloxacin inpureand dosage forms by complexation with Fe(III) and Cu(II) ions. Int. Res. J. Pharm. Pharmacol.(2012)2(5): 97-102.
Guide for Industry,Bioanalytical Method Validation, U.S Department of Health andHuman Services Food and Drug Administration (FDA), (2001).
Bosque-Sendra JM, Almansa-Lopez E, Garcia-Campana AM, Caudros-Rodriguez L.Data analysis in the determination of stoichiometries and stability constants ofcomplexes. Anal. Sci. (2003) 19 (10): 1431-1439.
ICH Q2(R2), Validation of Analytical Procedures: Text and Methodology,adopted in November 2023.
West JC. Rapid HPLC Analysis of Paracetamol (Acetaminophen) in Blood andPostmortem Viscera. J. Anal. Toxicol.(1981)5 (3), 118-121.
Patil P, Machhi J. Development and validation of spectrophotometric method forestimation of sodium [2-[2,6-dichlorophenyl[(4-amino N-acetyl)phenyl acetate]-amino]phenyl acetate] in rat serum and its application in pharmacokinetics studies. Int. J. Chem. Sci.(2018) 2(6): 19-29.
Gibaldi MI, Perrier DO. Pharmacokinetics (2nd edn). Marcelly Dekker: New York. 1982. 121-123.
PHAR 7633 Basic Pharmacokinetics, Chapter 20, Non Compartmental Analysis. (2012) 1-10.
PHAR 7633 Basic Pharmacokinetics, Chapter 20, Non Compartmental Analysis. 2012, pp. 1-10.
Fajdetic A, Vinter A; Paljetak HC, Padovan J, Jakopovic IP, Kapic S.Synthesis, activity and pharmacokinetics of novel antibacterial 15-membered ring macrolones. Eur. J Med. Chem.(2011) 46(8):3388-3397.
Oscier CD, Milner QJ. Peri‐operative use of paracetamol. Anaesthesia.(2009) 64(1):65-72.
- Abstract Viewed: 419 times
- IJPS_Volume21_Issue1_Pages32-47 Downloaded: 408 times