DEVELOPMENT AND VALIDATION OF NEW RP-UPLC METHOD FOR THE DETERMINATION OF CEFDINIR IN BULK AND DOSAGE FORM
DOI:
https://doi.org/10.22159/ijpps.2018v10i1.23256Keywords:
UPLC, Cefdinir, Method development, ValidationAbstract
Objective: The objective of the study was to develop and validate a new rapid and sensitive reverse phase ultra-performance liquid chromatographic (RP-UPLC) method for determination of cefdinir in bulk drug and dosage form.
Methods: Separation was achieved with an Acquity SB C18 (100 × 2 mm) 1.8μm column with an isocratic mobile phase containing a mixture of orthophosphoric acid and acetonitrile (60:40 v/v) and pH adjusted to 2.8. The flow rate of the mobile phase was 0.3 ml/min with a column temperature of 30 °C and detection wavelength at 285 nm.
Results: The method was validated with respect to linearity, accuracy, precision, detection limits, robustness and specificity. The precision of the results, stated as the relative standard deviation was below 1.5%. The calibration curve was linear over a concentration range from 25 to 150μg/ml with a correlation coefficient of 0.9993. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The recovery of cefdinir was found to be in the range of 98 to 102%, whereas the detection limits were found to be 0.17 and 0.51µg/ml. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stability-indicating ability of the developed UPLC method.
Conclusion: The developed method was validated with respect to linearity, accuracy, precision limit of detection and quantification, robustness and specificity. The method was applied successfully for the determination of cefdinir in tablets.
Downloads
References
Peter M, Ladislav N. On the importance of pharmaceutical analysis. Res Rev J Pharm Anal 2015;4:13-4.
Himanshu Gupta, Aqil M, Khar RK, Ali A, Sharma A, Prakash C. Development and validation of a stability-indicating RP-UPLC method for the quantitative analysis of sparfloxacin. J Chromatogr Sci 2014;7:135-40.
Ram G, Navneet Singh, Srinivas KS, Binayak D, Ahmed A. UPLC method development and validation for cefditoren pivoxil in the active pharmaceutical ingredient. J Appl Pharm Sci 2011;1:149-53.
Raja Abhilash P, Venkateshwar Rao J. Development and validation of a new RP-UPLC method for the quantitative determination of olanzapine in tablet dosage form. Asian J Pharm Clin Res 2013;6:178-81.
Malleswararao CSN, Suryanarayana MV, Mukkanti K. Simultaneous determination of sitagliptin phosphate monohydrate and metformin hydrochloride in tablets by a validated UPLC method. Sci Pharm 2012;80:139-52.
Antil P, Kaushik D, Jain G, Srinivas KS, Indu Thakur. UPLC method for simultaneous determination of valsartan and hydrochlorothiazide in drug products. J Chromatogr Sep Tech 2013;4:1-5.
Kishore G, Kamala Babu B, Guru Charana Das V. RP-HPLC method for the estimation of ceftriaxone and cefdinir third-generation cephalosporin in the dosage form. Int J Mod Chem Appl Sci 2016;3:392-7.
Hasheem H, GoudS AA, Hassan W. Development and validation of a rapid stability indicating the chromatographic determination of Cefdinir in bulk powder and dosage form using monolithic stationary phase. J Liq Chromatogr Relat Technol 2013;36:2292–306.
Shahed GM, Ashik U, Maruf A Al, Ahmed MU, Mohammad SI, Nahar Z, et al. a Simple RP−HPLC method for the determination of cefdinir in human serum: validation and application in a pharmacokinetic study with a healthy bangladeshi male volunteer. J Pharm Sci 2011;10:109-16.
Shah PB, Pundarikakshudu K. Difference spectroscopic and reverse phase HPLC methods for the estimation of cefdinir in pharmaceutical dosage forms. Indian J Pharm Sci 2006;68:90-3.
Rajeev J, Keisham R, Nimisha J. Electrochemical evaluation and determination of cefdinir in dosage form and biological fluid at mercury electrode. J Electrochem Soc 2007;154:199-204.
Khan A, Iqbal Z, Khan MI, Javed K, Khan A, Ahmad L, et al. Simultaneous determination of cefdinir and cefixime in human plasma by RP-HPLC/UV detection method: method development, optimization, validation, and its application to a pharmacokinetic study. J Chromatogr B 2011;879:2423-9.
Chen ZJ, Zhang J, Yu JC, Cao GY, Wu XJ, Shi YG. A selective method for the determination of Cefdinir in human plasma using liquid chromatography electrospray ionization tandem mass spectrometry. J Chromatogr B 2006;834:163-9.
Abdel-Aziz O, Farouk M, Nagi R, Abdel-Fattah L. Simple spectrophotometric and HPTLC-densitometric methods for determination of cefdinir in bulk powder and pharmaceuticals and in presence of its hydrolytic degradation products. J Appl Pharm Sci 2014;4:129-36.
Balaji N, Sivaraman VR, Neeraja P. A validated uplc method for the determination of process-related impurities in the antimigraine bulk drug. J Appl Chem 2013;3:20-8.
Yanamandra R, Vadla CS, Puppala UM, Patro B, Murthy YLN, Parimi AR. Development and validation of a rapid RP-UPLC method for the simultaneous estimation of bambuterol hydrochloride and montelukast sodium from tablets. Indian J Pharm Sci 2012;74:116-21.
Shashikant B, Landge, Sanjay A, Jadhav, Shrihari P, Vishwambar, et al. Development and validation of an RP-UPLC method for the determination of iloperidone, its related compounds and degradation products in bulk and dosage form. Am J Anal Chem 2014;5:969-81.
Richard T, Kenneth D, Ruhi U, Joel S, Blake WE. Development and validation of a UPLC method for rapid and simultaneous analysis of proton pump inhibitors. Pharm Sci-Tech 2015;16:30–4.
Published
How to Cite
Issue
Section
