AQBD ASSISTED SPECTROPHOTOMETRIC METHODS FOR THE QUANTIFICATION OF CEFIXIME TRIHYDRATE USING TWO OXIDATIVE COUPLING AGENTS: QbD assisted Spectrophotometric estimation of Cefixime trihydrate

KOKILAMBIGAI K S; LAKSHMI K S

doi:10.22159/ajpcr.2019.v12i7.33682

Authors

KOKILAMBIGAI K S Department of Pharmaceutical Analysis, SRM College of Pharmacy, SRM Institute of Science and Technology, Kancheepuram, Tamil Nadu,
LAKSHMI K S Department of Pharmaceutical Analysis, SRM College of Pharmacy, SRM Institute of Science and Technology, Kancheepuram, Tamil Nadu, India. http://orcid.org/0000-0003-3664-7466

DOI:

https://doi.org/10.22159/ajpcr.2019.v12i7.33682

Keywords:

Cefixime trihydrate,, Quality by design,, Fractional factorial design,, Response surface methodology, Central, Central composite design,, Visible spectrophotometry,, Validation

Abstract

Objective: The present study focuses on developing two visible spectrophotometric methods for cefixime trihydrate (CFT) by the utilization of analytical quality by design space concept. The critical method variables were screened and optimized by factorial design.

Methods: In methods A and B, CFT reacts with 3-methyl-2-benzothiazolinone hydrazone hydrochloride in an acidic medium having λmax at 630 nm and CFT reacts with 1, 10 phenanthroline (Phen) showing λmax at 510 nm, respectively. Fractional factorial design was employed for the initial screening of independent variables for both methods. The main, interaction, and quadratic effects of the most significant factors on the preferred response (absorbance) for methods A and B were studied employing central composite design (CCD) with response surface methodology.

Results: The method was linear (r2=0.9983 and 0.9986 for methods A and B), accurate (mean recovery = 100.06% and 99.26% for methods A and B), precise (relative standard deviation, % relative standard deviation = 0.9214, 1.025 and 0.1919, 0.2136 for methods A and B).

Conclusion: The outcome of the proposed work has evidently revealed that quality by design concept can be efficiently enforced in the optimization of spectrophotometric technique for the quantification of CFT in pharmaceutical raw materials and formulations by minimum experimental runs.

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References

Tripathi KD. Essentials of Medical Pharmacology. 5th ed. New Delhi: Jaypee Brothers Medical Publishers; 2013.

Pundarikakshudu K, Shah PB. Spectrophotometric, difference spectroscopic, and RP-HPLC methods for the determination of cefixime in pharmaceutical formulations. J AOAC Int 2006;89:987-94.

Saleh GA, Askal HF, Darwish IA, EL-Shorbagi AA. Spectrophotometric analytical study for the charge transfer complexation of certain cephalosporin with chloranilic acid. Anal Sci 2003;19:281-7.

Pareek V, Tambe SR, Bhalerao SB. Role of different hydrotropic agents in spectrophotomteric and chromatographic estimation of cefixime. Int J Pharm Bio Sci 2010;1:1-10.

Virupaxappa BS, Shivaprasad KH, Latha MS. A simple method for the spectrophotometric determination of cefixime in pharmaceuticals. Asian J Res Chem 2011;4:1275-7.

Uri JV, Jain TC. Colorimetric detection and spectrophotometric determination of the aminothiazolyl-alkoxyimino p-lactams. J Antibiot 1986;39:669-75.

El Walily AF, Gazy AA, Belal SF, Khamis EF. Use of cerium (IV) in the spectrophotometric and spectrofluorimetric determinations of penicillins and cephalosporins in their pharmaceutical preparations. Spectrosc Lett 2000;33:931-48.

Agbaba D, Eric S, Karlijikovic-Rajic K, Valdimirov S, Zivanov-Stakic D. Spectrophotometric determination of certain cephalosporin’s using ferrihydroxamate method. Spectrosc Lett 1997;30:309-19.

Patil VP, Gaikwad AD, Kulkarni VS, Devdhe SJ, Kale SH. Spectrophotometric determination of cefixime in bulk drug using ninhydrin-a model approach. Inventi Rapid Pharm Anal Qual Assur 2012;2:269.

Ali Ahmed MS, Elbashir AA, Aboul-Enein YH. New spectrophotometric method for determination of cephalosporins in pharmaceutical formulations. Arabian J Chem 2015;8:233-9.

Shankar DG, Sushma K, Lakshmi RV, Rao YS, Reddy MN, Murthy TK. Spectrophotometric determination of cefixime trihydrate. Asian J Chem 2001;13:1649-51.

Khan MN, Qayum A, Ur Rehman U, Gulab H, Idrees M. Spectrophotometric method for quantitative determination of cefixime in bulk and pharmaceutical preparations using ferroin complex. J Appl Spectrosc 2015;82:705-11.

Jain R, Gupta VK, Jadon N, Radhapyari K. Voltammetric determination of cefixime in pharmaceutical sand biological fluids. Anal Biochem 2010;407:79-88.

Kandikonda S, Akula G, Pandey VP, Kudaravalli S, Bhupathi S, Reddy SB. Validation of RP-HPLC method for the estimation of cefixime in cefixime oral suspension. Int J Pharm Technol 2010;2:385 95.

Raj KA, Yada D, Prabhu C, Manikantan S. Determination of cefixime trihydrate and cefuroxime axetil in bulk drug and pharmaceutical dosage form by HPLC. Int J ChemTech Res 2010;2:334-6.

Nanda RK, Gaikwad J, Prakash A. Estimation of cefixime and ordinazole in its pharmaceutical dosage form by spectrophotometric method. J Pharm Res 2009;2:1264-6.

Kumar R, Singh P, Singh H. Development of colorimetric method for the analysis of pharmaceutical formulation containing both ofloxacin and cefixime. Int J Pharm Pharm Sci 2011;3:178-9.

Sharma R, Pathodiya G, Mishra GP, Sharma M. Simultaneous estimation and validation of cefixime trihydrate and ordinazole in bulk and tablets using hydrotropic solubilizing agents. J Pharm Res 2010;3:2953-5.

Rathinavel G, Mukherjee PB, Valarmathy J, Samueljoshua L, Ganesh M, Sivakumar T, et al. A validated RP-HPLC method for simultaneous estimation of cefixime and cloxacillin in tablets. E-J Chem 2005;5:648 51.

Khandagle KS, Gandhi SV, Deshpande PB, Gaikwad NV. Simple and sensitive RP-HPLC method for simultaneous estimation of cefixime and ofloxacin in combined tablet dosage form. Int J Pharm Pharm Sci 2011;3:46-8.

Dhoka MV, Gawande VT, Joshi PP. Simultaneous estimation of cefixime trihydrate and erdosteine in pharmaceutical dosage form by using RP-HPLC. Int J ChemTech Res 2010;2:79-87.

Dhola VM, Gawande TV, Joshi PP. Validated HPTLC method for simultaneous quantification of cefixime trihydrate and erdosteine in bulk and combined dosage form. Eurasian J Anal Chem 2013;8:99-106.

Eric-Jovanovic S, Agbaba D, Zivanov-Stakic D, Vladimirov S. HPTLC determination of ceftriaxone, cefixime and cefotaxime in dosage forms. J Pharm Biomed Anal 1998;18:893-8.

Ravichandran V, Sumithra M. Application of quality by design (CCD Technique) for simultaneous estimation of cefixime and ofloxacin by HPTLC method. Int J Pharm Pharm Sci 2016;8:200-8.

Lewis GA, Mathieu D, Phan-Tan-Luu R. Pharmaceutical Experimental Design. New York: MARCEL Dekee Inc.; 1999.

Stat-Ease Inc. Design-Expert® Version: 10.0.1.0 64-bit; User guide: Data Analysis and Quality Tools. Minneapolis: Stat-Ease Inc.; 2016.

Ferreira SL, Bruns RE, Ferreira HS, Matos GD, David JM, Brandão GC, et al. Box-behnken design: An alternative for the optimization of analytical methods. Anal Chim Acta 2007;597:179-86.

Benzerra MA, Santelli RE, Oliveria EP, Villar LS, Escaleira LA. Response surface methodolgy (RSM) as a tool for optimization in analytical chemistry. Talanta 2008;76:965-77.

Awotwe-Otoo D, Agarabi C, Faustino PJ, Habib MJ, Lee S, Khan MA, et al. Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate. J Pharm Biomed Anal 2012;62:61-7.

ICH. Validation of Analytical Procedures: Text and Methodology Q2 (R1): International Conference on Harmonization. Geneva: IFPMA; 2005.