DEVELOPMENT AND VALIDATION OF A SIMPLE AND COST-EFFECTIVE UV SPECTROPHOTOMETRIC METHOD FOR QUANTIFYING LINEZOLID
DOI:
https://doi.org/10.22159/ijap.2024v16i3.50556Keywords:
Linezolid, UV spectrophotometric method, Validation, Absorption maxima, Analytical methodAbstract
Objective: This study focuses on the development and validation of a sensitive, simple, accurate, precise and cost-effective Ultraviolet-Visible (UV) spectrophotometric method for the quantification of Linezolid, a widely used antibiotic in pharmaceutical formulations.
Methods: The analysis utilized a solvent system comprising 80% water and 20% methanol (v/v). The absorbance of standard solutions was measured and a calibration curve was constructed. Various analytical performance parameters, including linearity, range, precision, accuracy, Limit of Detection (LOD), Limit of Quantification (LOQ) and ruggedness, were determined following the International Conference on Harmonization (ICH) Q2 (R1) guidelines.
Results: The maximum absorption peak (λmax) of Linezolid was determined to be 251 nm in the selected medium. Beer-Lambert’s law was valid in the concentration range of 0.5–9 μg/ml, with a high correlation coefficient (R2) of 0.9955. The proposed method exhibited a recovery ranging from 99.08 to 100.37% with % Relative Standard Deviation (RSD) value consistently below 2%.
Conclusion: The study findings confirm the accuracy, precision and reproducibility of the developed method. Additionally, it is characterized by its simplicity, affordability, and time efficiency. Thus, this method can be effectively employed for the quantification of Linezolid in lipid nanoparticles.
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Khatri SK, Rathnanand M, RN. Formulation and evaluation of wound healing activity of linezolid topical preparations on diabetic rats. Int J Appl Pharm. 2016;8(3):30-6. doi: 10.22159/ijap.2016v8i3.12889.
Patel SA, Patel PU, Patel NJ, Patel MM, Bangoriya UV. Determination of linezolid in pharmaceutical dosage forms by liquid chromatography and ultraviolet spectroscopy. J AOAC Int. 2007;90(5):1272-7. doi: 10.1093/jaoac/90.5.1272, PMID 17955972.
Buerger C, Joukhadar C, Muller M, Kloft C. Development of a liquid chromatography method for the determination of linezolid and its application to in vitro and human microdialysis samples. J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Oct 25;796(1):155-64. doi: 10.1016/j.jchromb.2003.08.019, PMID 14552826.
Nagaraju PT, Sreenivasa Rao M, Ravi Kumar C, Mabhasha D, Venu Gopal K, Murali Krishna NV. UV-spectrophotometric method development and validation for determination of linezolid in pharmaceutical dosage form. Res Rev J Pharm Anal. 2014;3(3):23-7.
Yang G, Yan Y, Mao J, Liu H, Chen M, Zhang N. Development and validation of an HPLC-UV method for quantitation of linezolid: application to resistance study using in vitro PK/PD model. Infect Drug Resist. 2021;14:5089-98. doi: 10.2147/IDR.S343200, PMID 34880634.
Cattaneo D, Baldelli S, Conti F, Cozzi V, Clementi E. Determination of linezolid in human plasma by high-performance liquid chromatography with ultraviolet detection. Ther Drug Monit. 2010 Aug;32(4):520-4. doi: 10.1097/FTD.0b013e3181d5eeee, PMID 20300050.
Baietto L, D’Avolio A, Ariaudo A, Corcione S, Simiele M, Cusato J. Development and validation of a new UPLC-PDA method to quantify linezolid in plasma and in dried plasma spots. J Chromatogr B Analyt Technol Biomed Life Sci. 2013 Oct 1;936:42-7. doi: 10.1016/j.jchromb.2013.08.003, PMID 23973533.
Ali SM, Bharath P, V SR, DR. Development and validation of RP-LC method for linezolid in pharmaceutical formulations. SSRG-IJAC. 2022;9(1):18-24. doi: 10.14445/23939133/IJAC-V9I1P103.
Mohapatra S, Annapurna MM, Ravi Kumar BVV, Anwar M, Warsi MH, Akhter S. Validated stability indicating RP-HPLC method for the estimation of linezolid in a pharmaceutical dosage form. J Liq Chromatogr Relat Technol. 2011 Nov 1;34(18):2185-95. doi: 10.1080/10826076.2011.585548.
Zander J, Maier B, Zoller M, Teupser D, Vogeser M. Quantification of linezolid in serum by LC-MS/MS using semi-automated sample preparation and isotope dilution internal standardization. Clin Chem Lab Med. 2014;52(3):381-9. doi: 10.1515/cclm-2013-0594, PMID 24158423.
Saviano AM, Francisco FL, Lourenço FR. Rational development and validation of a new microbiological assay for linezolid and its measurement uncertainty. Talanta. 2014 Sep 1;127:225-9. doi: 10.1016/j.talanta.2014.04.019, PMID 24913880.
International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Validation of analytical procedures: text and methodology. Draft revised guidance on Q2. Vol. R1; 2005. p. 6-13. Available from: https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf.
Jain PS, Chaudhari AJ, Patel SA, Patel ZN, Patel DT. Development and validation of the UV-spectrophotometric method for determination of terbinafine hydrochloride in bulk and in formulation. Pharm Methods. 2011 Jul;2(3):198-202. doi: 10.4103/2229-4708.90364, PMID 23781456, PMCID PMC3658052.
Yasir M, Sara UVS. Development of UV spectrophotometric method for the analysis of antipsychotic drug. Res J Pharm Technol. 2014;7(6):638-42.
Friedrich RB, Ravanello A, Cichota LC, Rolim CMB, Beck RCR. Validation of a simple and rapid UV spectrophotometric method for dexamethasone assay in tablets. Quim Nova. 2009;32(4):1052-4. doi: 10.1590/S0100-40422009000400038.
Kaur T, Kaur S, Kaur P. Development and validation of UV-spectrophotometric methods for determination of gemcitabine hydrochloride in bulk and polymeric nanoparticles. Int J App Pharm. 2017 Sep 15;9(5):60-5. doi: 10.22159/ijap.2017v9i5.19726.
Shirwar M, Birajdar S, Garad S, Kumbhar S. Development and validation of novel UV-visible spectrophotometric method for estimation of tepotinib in bulk and in pharmaceutical formulation. Int J Pharm Pharm Sci. 2023;15(9):32-6. doi: 10.22159/ijpps.2023v15i9.48431.
Sapavadiya VK, Sapavadiya MV, Shelat PK, Lalwani AN. Development and validation of new RP-HPLC method for the estimation of linezolid in linezolid gel. Int J Pharm Pharm Sci. 2015;7(4):250-4.
Naik AD, Pai SPN. Spectrophotometric method for estimation of linezolid in tablet formulation. Asian J Biomed Pharm Sci. 2013;3(21):4-6.
Swartz ME, Krull IS. Analytical method validation: accuracy in quantitation. LC GC N Am. 2005;23(1):46-52.
Singh S, Sharma N, Singla YP, Arora S. Development and validation of UV-spectrophotometric method for quantitative estimation of nefopam hydrochloride in polymethacrylate nanospheres. Int J Pharm Pharm Sci. 2015;8(1):414-9.
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