SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF AMIKACIN IN PURE AND PHARMACEUTICAL DOSAGE FORM
Objective: The aim of the study was to develop an easy, sensible and rapid method for the estimation of amikacin in both pure and marketed formulation using the spectrophotometric method.
Methods: Due to lack of chromophoric group in the amikacin, it was derivatized with 0.1 mmol chloranillic acid reagent. For the estimation of amikacin, Shimadzu UV-1700 model spectrophotometer with UV probe software was used. The method was based on simple charge transfer complexation of the drug with a p-chloranillic acid reagent to give a purple coloured product which was measured at 524nm against blank solution.
Results: The derivatised product of amikacin was detected at a wavelength of 524 nm. Linearity was observed with the concentration range of 20-100 Âµg/ml with a regression coefficient of 0.9803. Results of all the parameters were within the acceptance criteria with % RSD less than 2.
Conclusion: The spectroscopic method was validated as per ICH guidelines and was found to be applicable for routine quantitative analysis of amikacin in marketed formulations also. The results of linearity, precision, accuracy LOD and LOQ were within the specified limits. The method is highly sensitive, robust, reproducible and specific.
2. Ovalles JF, Brunetto Mdel R, Gallignani M. A new method for the analysis of amikacin using 6-aminoquinolyl-N-hydroxy-succinimidyl carbamate (AQC) derivatization and high-performance liquid chromatography with UV-detection. J Pharm Biomed Anal 2005;39:294-8.
3. Galanakis EG, Megoulas NC, Solich P, Koupparis MA. Development and validation of a novel LC non-derivatization method for the determination of amikacin in pharmaceuticals based on evaporative light scattering detection. J Pharm Biomed Anal 2006;40:1114-20.
4. Ryan JA. Colorimetric determination of gentamicin, kanamycin, tobramycin, and amikacin aminoglycosides with 2,4-dinitrofluorobenzene. J Pharm Sci 1984;73:1301-2.
5. Zawilla NH, Li B, Hoogmartens J, Adams E. Improved reversed-phase liquid chromatographic method combined with pulsed electrochemical detection for the analysis of amikacin. J Pharm Biomed Anal 2007;43:168-73.
6. Maitra SK, Yoshikawa TT, Steyn CM, Guze LB, Schotz MC. Amikacin assay in serum by high-performance liquid chromatography. Antimicrob Agents Chemother 1978;14:880-5.
7. SÃ¡nchez Martinez ML, Aguilar Caballos MP, Gomez Hens A. Selective kinetic determination of amikacin in serum using long-wavelength fluorimetry. J Pharm Biomed Anal 2004;34:1021-7.
8. Dave Vimal M. Development and validation of an RP-HPLC method for simultaneous estimation of cefepime hydrochloride and amikacin sulphate in injection dosage form. J Pharm Sci Biosci Res 2012;2:58-62.
9. Nicoli S, Santi P. Assay of amikacin in the skin by high-performance liquid chromatography. J Pharm Biomed Anal 2006;41:994-7.
10. Baietto L, D'Avolio A, De Rosa FG, Garazzino S, Michelazzo M, Ventimiglia G, et al. Development and validation of a simultaneous extraction procedure for HPLC-MS quantification of daptomycin, amikacin, gentamicin, and rifampicin in human plasma. Anal Bioanal Chem 2010;396:791-8.
11. Fathima A, Rao S, Venkateshwarlu G. Quantitative determination of drugs and pharmaceuticals using p-chloranilic acid as a reagent. Int J Chem Tech Res 2012;4:79-91.
12. Darwish IA, Refaat IH. Spectrophotometric analysis of selective serotonin reuptake inhibitors based on the formation of charge-transfer complexes with tetracyanoquinodimethane and chloranilic acid. J AOAC Int 2006;89:326-33.
13. ICH, Q2B, Validation of Analytical Procedures: Methodology, International Conference on Harmonization, Geneva; 1996. p. 1.
14. ICH, Q2(R1), Validation of analytical procedures: Text and Methodology; 1995.
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