ZERO, FIRST, SECOND ORDER DERIVATIVE AND AREA UNDER CURVE SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF CEFIXIME TRIHYDRATE IN PHARMACEUTICAL FORMULATION
Keywords:Cefixime Trihydrate, Area under the curve method, UV visible spectrophotometry, Zero, First and second order derivative spectrum
Objective: A simple, accurate, precise and specific zero, first, second order and area under curve spectrophotometric methods has been developed for determination of Cefixime Trihydrate in its tablet dosage form by using methanol as a solvent.
Methods: (1) Derivative spectrophotometric methods: The amplitudes in the zero order derivative of the resultant spectra at 287 nm, first order derivative of the resultant spectra at 307 nm and second order derivative of the resultant spectra at 307 nm were selected to find out cefixime trihydrate in its tablet dosage form by using methanol as a solvent.
(2) Area under curve (Area Calculation): The proposed area under the curve method involves measurement of area at selected wavelength ranges. Two wavelength ranges were selected 281-295 nm for estimation of cefixime trihydrate.
Results: The linearity was found to be 5-25 Î¼g/ml for cefixime trihydrate. The mean % recoveries were found to be 100.97%, 100.58%, 99.60% and 101.14% of zero, first, second derivatives and area under curve method of cefixime trihydrate. For Repeatability, Intraday precision, Interday precision, % RSD were found to be 0.2106, 0.2901 and 0.22569,0.2571 for zero order, 0.0008,0.6438 and 5.7700,0.3201 for first order, 5.2358,0.5701 and 0.0003,1.8601 for second order and 4.2571,0.7251 and 0.0582,1.2563 for area under the curve method respectively. Limit of Detection and Quantitation were found to be 0.42Î¼g/ml and 1.35Î¼g/ml for zero order, 0.416Î¼g/ml and 0.952Î¼g/ml for first order, 0.718Î¼g/ml and 2.314Î¼g/ml for second order, 0.819Î¼g/ml and 2.429Î¼g/ml for area under curve method respectively. Assay results of market formulation were found to be 100.97%, 100.58%, 99.60% and 101.14% for zero order, first order, second order and area under the curve method respectively. The proposed method has been validated as per ICH guidelines and successfully applied to the estimation of cefixime trihydrate in its Tablet dosage form.
Conclusion: The developed methods can be concluded as accurate, sensitive and precise and can be easily applied to the pharmaceutical formulation.
Shah PB, Pundarikakshudu K. Spectrophotometric, Difference spectroscopic and high-performance liquid chromatographic methods for the determination of cefixime in pharmaceutical formulations. J AOAC Int 2006;89(2):987-94.
Rajeshri D Chaudhari, Vishruti H Choksi, Tanvi Divan, Bhavna A Patel, Shraddha J Parmar. Development and validation of first order derivative spectrophotometric method for estimation of lacosamide in bulk and tablet dosage form. Asian J Pharm Clin Res 2013;6(3):162-4.
Ani R. Comparative. Multicenter studies of cefixime trihydrate and amoxicillin in the treatment of respiratory tract infections. Am J Med 1988;85(3A):6-13.
Fera M, Carbone M, Foch A. Activity of cefixime trihydrate against helicobacter pylori. Int J Antimicrob Agents 1993;3(1):105-8.
Sagar Vaghasia, Aashka Jani. Development and validation of spectrophotometric area under curve method for simultaneous estimation of tolperisone hydrochloride and diclofenac sodium in their combined tablet dosage form. Int J Pharm Pharm Sci 2013;5(4):214-9.
Verhoef J, Gillissen A. Resistant Haemophilus influenzae in community acquired respiratory tract infections: a role for Cefixime Trihydrate. Int J Antimicrob Agents 2003;21(2):501-9.
Iravani A, Richard G. A Double-blind multicenter comparative study of the safety and efficacy of cefixime trihydrate versus amoxicillin in the treatment of acute urinary tract infections in adult patients. Am J Med 1988;85(3A):17-23.
Gandhi S, Rajput S. Study of degradation profile and development of stability indicating methods for cefixime trihydrate. Indian J Pharm Sci 2009;71(4):438-42.
Sivakumar Ch V, Shubham Gupta, Amerendra K Chandan, Chandrakala Gunturu, Meera Indracanti. Determination of cefixime and ofloxacin by ratio spectra and zero crossing difference spectrophotometry. Int J Pharm Pharm Sci 2012;4(3):118-23.
Deshpande M, Kasture V, Gosavi S. Application of HPLC and HPTLC for the simultaneous determination of cefixime trihydrate trihydrate and ambroxol hydrochloride in pharmaceutical dosage form. Eurasian J Anal Chem 2010;5(3):227-38.
Arshad, Gauhar S, Bano R. Development of HPLC-UV method for Analysis of Cefixime In Raw Material and In Capsule. Jordan J Pharm Sci 2009;2(1):53-65.
Virypaxappa BS, Shivaprasad KH, Latha MS. A simple method for spectrophotometric determination of cefixime in pharmaceuticals. Int J Chem Res 2010;2(1):23-30.
Dhoka MV, Vaidya Pravin D, Pande Amol V, Arora Aseem A. Development and validation of analytical method for estimation of cefixime in swab samples. Int J Chem Tech Res 2011;2(4):1918-23.
Singh BK, Parwate DV, Srivastava S, Shukla SK. Thin-Layer chromatographic selective and stability-indicating method for assay of cefiximein pharmaceuticals. J Planar Chromatogr 2011;24(6):524â€“8.
Dhoka MV. Validated HPTLC method for Determination of Cefixime Trihydrate and Erdosteine in Bulk and combination pharmaceutical dosage form. Eurasian J Anal Chem 2011;6(1):227-36.
Ramesh M, Kanaka DM, Sravani A, Snehalatha T, Thimmareddy D. A new stability indicating validated RP-HPLC method for the simultaneous estimation of azithromycin and cefixime in bulk and pharmaceutical dosage forms. Asian J Res 2012;5(8):1067-73.
Khandagle KS, Gandhi SV, Deshpande PB. HPTLC determination of cefixime trihydrate and ofloxacin in combined tablet dosage form. J Chem Pharm Res 2010;2(5):92-6.
Devika G, SudhakarM, Rao VJ. Validated TLC Densitometric method for the quantification of cefixime trihydrate and ornidazole in bulk drug and in tablet dosage form. Scholars Res Library Der Pharm Chem 2010;2(6):97-104.
Basu A, Basak K, Chakraborty M, Singh RI. Development and validation of high performance liquid chromatographic method for simultaneous estimation of potassium clavulanate and cefixime trihydrate in tablet dosage form. J Pharm Res 2011;4(5):1319-21.
Pawar SJ, Kale AP, Amrutkar MP, Jagade JJ, Pore NS, Bhosale AV. HPTLC Estimation of Cefixime and Cloxacillin in tablet dosage form. Asian J Res Chem 2010;3(2):299-301.
Deshpande MM, Kastureb VS, Gosavi SA. Application of HPLC and HPTLC for the simultaneous determination of Cefixime Trihydrate and Ambroxol hydrochloride in pharmaceutical dosage form. Eurasian J Anal Chem 2010;5(3):227-38.
Zende lovska D. HPLC method for determination of Cefixime and Cefotaxime in human plasma. Bull Chem Technol Maced 2003;22(1):39-45.
Khan U, Sharif S, Ashfaq M, Asghar N. Simultaneous determination of potassium clavulanate and cefixime in synthetic mixtures by high performance liquid chromatography. J AOAC Int 2008;91(7):744-9.
Kumudhavalli M, Sahu S, Abhiteja K, Jayakar B. Development and Validation of RP-HPLC method for simultaneous determination of cefixime and potassium clavulanate in tablet dosage form. Int J Pharm Recent Res 2010;2(2):27-41.
Sakane K, Kawabata K, Inamoto Y, Yamanaka H, Takaya T. Research and development of new oral cephems, cefixime and cefdinir. Yakugaku Zasshi 1993;113(9):605-26.
Memon IA, Billoo AG, Memon HI. Cefixime an oral option for the treatment of multidrug-resistant enteric fever in children. South Med J 1997;90(12):1204-7.
Rathinavel G, Mukherjee PB, Valarmathy, Samueljoshua, Ganesh M, Sivakumar T, Saravanan T. A Validated RPâ€“HPLC method for simultaneous estimation of Cefixime and Cloxacillin in tablets. E J Chem 2008;5(3):648-51.
International Conference on Harmonization (ICH) of Technical Requirements for the registration of Pharmaceuticals for Human use, Validation of Analytical Procedures Methodology; ICH-Q2(R1), Geneva; 1996. p. 1-8.