Application of Ion-Pair Complexation Reaction for the Spectrophotometric Determination of Clarithromycin in Pharmaceutical Formulations
Abstract
Two simple, rapid, sensitive, selective and extraction-free spectrophotometric methods have been developed for the determination of clarithromycin (CLR) both in pure form and in pharmaceutical formulations. The developed methods are based on ion-pair complexation reaction between CLR and two sulphonphthalein acid dyes, bromothymol blue (BTB) and bromocresol purple (BCP). The yellow colored products were measured spectrophotometrically at 416 nm and 418 nm for BTB and BCP, respectively. Beer’s law is obeyed over the ranges of 0.5–25.0 µg/ml and 1.0–25.0 µg/ml, for BTB method and BCP method, respectively. The apparent molar absorptivities and Sandell’s sensitivities (in L mol–1 cm–1 and µg cm–2 per 0.001 absorbance unit, respectively) were 2.01 ´ 104 and 0.0373 for BTB method, and 2.52 ´ 104 and 0.0297 for BCP method. The limits of detection (LOD) and quantification (LOQ) for both the methods are calculated. The developed methods were successfully applied to the determination of CLR in commercial tablets with good accuracy and precision and without detectable interference from common excipients. The accuracy and reliability of the developed methods were further established by parallel determination by the reference method and also by recovery studies via standard addition technique.
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British Pharmacopoeia, vols. I and II, Her Majesty’s Stationery Office, London, 2009.
Amini H, Ahmadiani A. Sensitive determination of clarithromycin in human plasma by high-performance liquid chromatography with spectrophotometric detection. J Chromatogr B 2005; 817: 193–197.
Srinivasu T, Rao BN, Mathrusri A, et al. Development and validation of high performance liquid chromatography method for quantification of related substances in clarithromycin powder for an oral suspension dosage form. Int J Anal Pharm Biomed Sci 2012; 1: 1–12.
Li P, Xiong AZ, Kuang P. Determination of clarithromycin in capsule by HPLC. Chin J Antibiot 2002; 27: 502–503.
Prasad Bathula SNV, Seshagiri Rao JVLN. A simple and sensitive liquid chromatography–mass spectrometry routine method for determination of clarithromycin in human plasma: Application to a clinical pharmacokinetic study. Clin Res Regul Aff 2010; 27: 60–66.
Gangishetty S, Verma S. RP-HPLC method development and validation for simultaneous estimation of clarithromycin and paracetamol. ISRN Anal Chem 2013; vol. 2013: Article ID 948547.
Morgan DK, Brown DM, Rotsch TD, et al. A reversed-phase high-performance liquid chromatographic method for the determination and identification of clarithromycin as the drug substance and in various dosage forms. J Pharm Biomed Anal 1991; 9: 261–269.
Koteswara Rao B, Manjula KR, Nageswara Rao M, et al. A new stability indicating RP-HPLC method for the simultaneous estimation of gemcitabine and clarithromycin in tarceva tablets. Indo Am J Pharm Res 2015; 5: 1613–1624.
JieMing S. Determination of the content of clarithromycin by HPLC with gradient elution. Pract Pharm Clin Remed 2009; 12: 418–419.
Tripathi GK, Singh S, Pandey BV. UV spectroscopy technique for analysis to clarithromycin for gastric pH sensitive formulation. J Chem Pharm Res 2013; 5: 1258–1262.
Rajesh KP, Somashekar S, Mallikarjuna GM, et al. A sensitive UV spectrophotometric analytical method development, validation and preformulation studies of clarithromycin. Research J Pharm Tech 2011; 4, 242–246.
Shah J, Rasul Jan M, Manzoo S. Extractive spectrophotometric methods for determination of clarithromycin in pharmaceutical formulations using bromothymol blue and cresol red. J Chin Chem Soc 2008; 55: 1107–1112.
Srinivasa Rao Y, Chowdary KPR, Seshagiriao JVLN. A new spectrophotometric method for determination of Clarithromycin tablets. Int J Chem Soc 2003; 1: 225–226.
Mruthyunjaya Rao R, Naresh S, Pendem K, et al. Simple spectrophotometric methods for determination of clarithromycin in pure state and tablets. Asian J Chem 2012; 24: 1535–1537.
Huakan L, Qiaofeng W, Yan Z. Spectrophotometric determination of clarithromycin based on charge transfer reaction between clarithromycin and alizarin. J Fourth Military Med Univ 2004; 23: 2206–2208.
Sultana N, Saeed Arayne M, Ali SN. The use of chloranilic acid for the spectrophotometric determination of three macrolides through charge transfer complex. Med Chem 2013; 3: 241–246.
Gouda AA, El-Sheikh R, Khalil KM. Spectrophotometric determination of certain macrolide antibiotics in pharmaceutical preparations. Int J TechnoChem Res 2015; 1: 11–24.
Darwish IA, Alqarni MA, Wani TA. Novel microwell assay with high throughput and minimum consumption for organic solvents in the charge transfer-based spectrophotometric determination of clarithromycin in pharmaceutical formulations, Chem Cent J 2013; 7: 172.
Khodavirdilo B, Khodavirdilo S, Najafi K. Simple spectrophotometric method for measuring antibiotics by using Fe(SCN)2+ complex pharmaceutical products. Recent Advances Pharm Sci Res 2013; 2: 103–109.
Jun L, Yan L, Guo-qing W, et al. Spectrophotometric determination of clarithromycin by charge-transfer reaction between clarithromycin and thymol blue. Chem Res Appl 2012; 4: 565–568.
Li HK, Xiao J.K. Spectrophotometric determination of clarithromycin based on the charge transfer reaction between clarithromycin and purpurin. Chinese J Anal Chem 2005; 33: 1327–1329.
Seshagiri Rao JVLN, Srinivasa Rao Y, Murthy TK, et al. Spectrophotometric estimation of clarithromycin in pharmaceutical formulations. Asian J Chem 2002; 14: 647–650.
Rao YS, Murthy TK, Chowdary KPR, et al. Assay of clarithromycin in pharmaceutical formulations. Indian Drugs 2002; 39: 348–349.
Sudheer P, Ganapathi PAV. Extractive spectrophotometric estimation of clarithromycin in pharmaceutical formulations. Indian Drugs 2001; 38: 358–360.
Srinivasa Rao Y, Rajani Kumar V, Seshagiri Rao JVLN. Visible spectrophotometric determination of clarithromycin in pharmaceutical solid dosage forms. Asian J Chem 2002; 14: 1791–1793.
Arbad BR, Jadhav SM. A simple spectrophotometric method for the determination of clarithromycin from pharmaceutical preparation. Asian J Chem 1999; 11: 1074–1076.
Sayed RA, Hassan WS, El-Mammli MY, et al. New spectrophotometric and conductometric methods for macrolide antibiotics determination in pure and pharmaceutical dosage forms using rose Bengal. J Spectrosc 2013; vol. 2013: Article ID 214270.
Walash MI, Rizk MS, Eid MI, et al. Spectrophotometric determination of four macrolide antibiotics in pharmaceutical formulations and biological fluids via binary complex formation with eosin. J AOAC Int 2007; 90: 1579–1587.
Srinivasa Rao Y, Jitendrababu V, Chowdary KPR, et al. Extractive spectrophotometric method for the determination of clarithromycin. Indian J Pharm Sci 2003; 65: 653–655.
Abdelmageed OH. Development and validation of a spectrophotometric method for the determination of macrolide antibiotics by using 2,4-dinitrophenylhydrazine. J AOAC Int 2007; 90: 364–371.
El-Adl SM, El-Sadek ME, Hassan MH. Bromometric estimation of cefixime, clarithromycin and clindamycin in bulk and dosage forms. Asian J Pharm Anal 2014; 4: 137–146.
El-Adl SM, El-Sadek ME, Hassan MH. Extractive spectro estimation of clarithromycin and clindamycin in bulk and dosage forms. Asian J Res Pharm Sci 2014; 4: 179–186.
Singhvi I. Visible spectophotometric methods for estimation of clarithromycin from tablet formulation. Indian J Pharm Sci 2002; 64: 480–482.
Nangude S, Vite M, Chugh N. Development of UV spectrophotometric method for estimation of clarithromycin in pharmaceutical dosage forms by using folin-ciocalteu reagent. Int J Pharm Chem Sci 2013; 2: 640–642.
El-Zaria ME, Etaiw SH. Two spectrophotometric methods for estimation of clarithromycin in pharmaceutical formulations and human plasma based on charge transfer complexes. Can J Anal Sci Spectrosc 2007; 52: 316–324.
Hua-Kan L, Yue L, Yu-Hua W. The spectrophotometric determination of clarithromycin based on the charge transfer reaction between clarithromycin and quinalizarin. Chinese J Spectrosc Lab 2005; 2: 356–359.
Hamdan II, Mishal AM. A spectroscopic method for quantitative determination of clarithromycin and roxithromycin. Saudi Pharm J 2000; 8: 191–197.
Ghoneim MM, El-Attar MA. Adsorptive stripping voltammetric determination of antibiotic drug clarithromycin in bulk form, pharmaceutical formulation and human urine. Chem Anal (Warsaw) 2008; 53: 689–702.
She-ying D, Xiao-feng H, Ting-lin H, et al. Investigation on determination of clarithromycin by differential pulse voltammetry. Chinese J Pharm Anal 2007; 27: 339–341.
International Conference on Hormonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, validation of analytical procedures: text and methodology Q2 (R1), Complementary Guideline on Methodology, London, 2005.
Ashour S, Chehna MF, Bayram R. Spectrophotometric determination of alfuzosin HCl in pharmaceutical formulations with some sulphonephthalein dyes. Int J Biomed Sci 2006; 2: 273–278.
This English Version of the Japanese Pharmacopoeia, The Ministry of Health, Labour and Welfare, 15th ed., 2006.
Amin AS, El-Fetouh Gouda AA, El-Sheikh R, et al. Spectrophotometric determination of gatifloxacin in pure form and in pharmaceutical formulation. Spectrochim Acta A Mol Biomol Spectrosc 2007; 67: 1306–1312.
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