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UV-spectrophotometry versus HPLC–PDA for dual-drug dissolution profiling: which technique provides a closer step towards green biowaiver concept? Novel application on the recent FDA-approved mixture Aleve pm

Abstract

Dissolution testing is a very significant tool that adds in vivo relevance to in vitro analytical data, thus providing a realistic in vitro/in vivo correlation. Dissolution profiling serves as a predictor of biological performance since the rate limiting step in the absorption of any drug is the rate of release from its pharmaceutical formulation. Being a routine procedure in quality control laboratories for initial approval process and scaling-up, the development of more and more eco-friendly methods for dissolution monitoring is considered as a worldwide trendy goal. In the present contribution, a comparison was highlighted between the two analytical techniques of utmost importance in acquisition of dissolution profiles: UV-spectrophotometry and HPLC–PDA focusing on the greenness of each one for further consolidation of the biowaiver concept. Both techniques were applied on the recently FDA-approved combination naproxen sodium (NAPR) and diphenhydramine hydrochloride (DIPH) formulated as Aleve pm® tablets. For the first time, this binary mixture was analyzed by three UV-spectrophotometric methods. NAPR was directly determined by zero-order spectrophotometry at 330 nm, where the spectrum of DIPH shows zero contribution. Whereas DIPH was determined by three simple methods exploiting the ratio spectra calculated using the spectrum of 20 µg/ml NAPR as a divisor. The first proposed method was ratio difference (RD), the second was ratio subtraction, and the last one was derivative ratio method. Being the simplest method, RD was the spectrophotometric method of choice that was applied in monitoring the dissolution of DIPH from Aleve pm® tablets. Although RD method has been widely described in many publications dealing with pharmaceutical analysis, it is the first article that opens a new horizon for RD method in the way of being a real-life application rather than only a method for determination. The second technique was a previously published HPLC–PDA, in which dissolution was then monitored by calculating the peak area of each component drug over time. Methods’ validation was performed agreeing with the ICH guidelines. The advantages and challenges of each technique are discussed in a side-by-side comparison giving a key to recognize which one can positively influence environmental well-being.

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References

  1. Abd El-Rahman MK, Riad SM, Abdel Gawad SA et al (2015) Stability indicating spectrophotometric and spectrodensitometric methods for the determination of diatrizoate sodium in presence of its degradation product. Spectrochim Acta Part A Mol Biomol Spectrosc. https://doi.org/10.1016/j.saa.2014.10.002

    Article  Google Scholar 

  2. Abd El-Rahman MK, Zaazaa HE, Eldin NB, Moustafa AA (2016) Just-dip-it (potentiometric ion-selective electrode): an innovative way of greening analytical chemistry. ACS Sustain Chem Eng 4:3122–3132. https://doi.org/10.1021/acssuschemeng.6b00138

    Article  CAS  Google Scholar 

  3. Abd El-Rahman MK, Riad SM, Fawaz EM, Shehata MA (2017) Three different spectrophotometric methods exploiting ratio spectra for the selective determination of iohexol in presence of its acidic degradate. Curr Pharm Anal. https://doi.org/10.2174/1573412913666171016163544

    Article  Google Scholar 

  4. Abdel-Halim LM, Abd-El Rahman MK, Ramadan NK et al (2016) Comparative study between recent methods manipulating ratio spectra and classical methods based on two-wavelength selection for the determination of binary mixture of antazoline hydrochloride and tetryzoline hydrochloride. Spectrochim Acta Part A Mol Biomol Spectrosc 159:98–105. https://doi.org/10.1016/J.SAA.2016.01.014

    Article  CAS  Google Scholar 

  5. Administration F and D (2015) Paving the way for personalized medicine: FDA’s role in a new era of medical product development. US Dep Health, Washington DC

    Google Scholar 

  6. Anand O, Yu LX, Conner DP, Davit BM (2011) Dissolution testing for generic drugs: an FDA perspective. AAPS J 13:328–335. https://doi.org/10.1208/s12248-011-9272-y

    Article  PubMed  PubMed Central  Google Scholar 

  7. Anastas P, Eghbali N (2010) Green chemistry: principles and practice. Chem Soc Rev 39:301–312. https://doi.org/10.1039/B918763B

    Article  CAS  PubMed  Google Scholar 

  8. Anastas PT, Warner JC (1998) Green chemistry. Frontiers

  9. Bhole RP, Shinde SS, Chitlange SS, Wankhede SB (2015) A high-performance thin layer chromatography (HPTLC) method for simultaneous determination of diphenhydramine hydrochloride and naproxen sodium in tablets. Anal Chem Insights 10:47

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. Conference I, Harmonisation ON, Technical OF et al (2005) ICH harmonised tripartite guideline validation of analytical procedures

  11. Costa P, Lobo J (2001) Modeling and comparison of dissolution profiles. Eur J Pharm Sci 13:123–133

    Article  CAS  PubMed  Google Scholar 

  12. Darwish HW, Hassan SA, Salem MY, El-Zeiny BA (2011) Three different spectrophotometric methods manipulating ratio spectra for determination of binary mixture of Amlodipine and Atorvastatin. Spectrochim Acta Part A Mol Biomol Spectrosc 83:140–148. https://doi.org/10.1016/j.saa.2011.08.005

    Article  CAS  Google Scholar 

  13. Darwish HW, Hassan SA, Salem MY, El-Zeany BA (2013) Three different methods for determination of binary mixture of Amlodipine and Atorvastatin using dual wavelength spectrophotometry. Spectrochim Acta Part A Mol Biomol Spectrosc 104:70–76. https://doi.org/10.1016/J.SAA.2012.11.079

    Article  CAS  Google Scholar 

  14. Eissa MS (2017) Simultaneous determination of the brand new two-drug combination for the treatment of hepatitis C: sofosbuvir/ledipasvir using smart spectrophotometric methods manipulating ratio spectra. Spectrochim Acta Part A Mol Biomol Spectrosc 183:362–370. https://doi.org/10.1016/j.saa.2017.04.052

    Article  CAS  Google Scholar 

  15. El-Rahman MKA, Al-Alamein AMA, Abdel-Moety EM, Fawaz EM (2017) Integrated gold-thiol based potentiometric sensors for in situ dual drug-protein binding studies on naproxen/diphenhydramine salts model. J Electrochem Soc 164:H1013–H1020. https://doi.org/10.1149/2.0531714jes

    Article  CAS  Google Scholar 

  16. Elzanfaly ES, Saad AS, Abd-Elaleem A-EB (2012) Simultaneous determination of retinoic acid and hydroquinone in skin ointment using spectrophotometric technique (ratio difference method). Saudi Pharm J 20:249–253. https://doi.org/10.1016/j.jsps.2012.03.004

    Article  PubMed  PubMed Central  Google Scholar 

  17. Gałuszka A, Migaszewski Z, Namieśnik J (2013) The 12 principles of green analytical chemistry and the SIGNIFICANCE mnemonic of green analytical practices. TrAC Trends Anal Chem 50:78–84. https://doi.org/10.1016/j.trac.2013.04.010

    Article  CAS  Google Scholar 

  18. Ge Z, Luo Y, Zhao X et al (2011) Simultaneous determination of ibuprofen and diphenhydramine HCl in orally disintegrating tablets and its dissolution by reversed-phase high performance liquid chromatography (RP-HPLC). Afr J Pharm Pharmacol 5:2100–2105

    CAS  Google Scholar 

  19. Guardia M, Garrigues S (2012) Handbook of green analytical chemistry. Wiley, New York

    Book  Google Scholar 

  20. ICH (2010) ICH harmonised tripartite guideline evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test general chapter Q4B annex 7(R2)

  21. Karam R (2015) Biowaivers: criteria and requirements prepared by Dr. Mazen Kurdi, pp 1–11

  22. Kassem MAA, Elmeshad AN, Fares AR (2014) Enhanced bioavailability of buspirone hydrochloride via cup and core buccal tablets: formulation and in vitro/in vivo evaluation. Int J Pharm 463:68–80. https://doi.org/10.1016/j.ijpharm.2014.01.003

    Article  CAS  PubMed  Google Scholar 

  23. Korany MA, Mahgoub H, Haggag RS et al (2017a) Green chemistry: analytical and chromatography. J Liq Chromatogr Relat Technol 40:839–852. https://doi.org/10.1080/10826076.2017.1373672

    Article  CAS  Google Scholar 

  24. Korany MA, Mahgoub H, Haggag RS et al (2017b) Development of a green stability-indicating HPLC–DAD method for the determination of donepezil hydrochloride in the presence of its related substance and degradation products. J Liq Chromatogr Relat Technol 40:930–942. https://doi.org/10.1080/10826076.2017.1386672

    Article  CAS  Google Scholar 

  25. Korany MA, Mahgoub H, Haggag RS et al (2018a) Chemometrics-assisted spectrophotometric green method for correcting interferences in biowaiver studies: application to assay and dissolution profiling study of donepezil hydrochloride tablets. Spectrochim Acta Part A Mol Biomol Spectrosc 199:328–339. https://doi.org/10.1016/J.SAA.2018.03.059

    Article  CAS  Google Scholar 

  26. Korany MA, Mahgoub H, Haggag RS et al (2018b) Green gas chromatographic stability-indicating method for the determination of Lacosamide in tablets. Application to in vivo human urine profiling. J Chromatogr B 1083:75–85. https://doi.org/10.1016/J.JCHROMB.2018.02.033

    Article  CAS  Google Scholar 

  27. Lotfy HM, Abdel-Monem Hagazy M (2012) Comparative study of novel spectrophotometric methods manipulating ratio spectra: an application on pharmaceutical ternary mixture of omeprazole, tinidazole and clarithromycin. Spectrochim Acta Part A Mol Biomol Spectrosc 96:259–270. https://doi.org/10.1016/J.SAA.2012.04.095

    Article  CAS  Google Scholar 

  28. Mabrouk MM, Hammad SF, Mansour FR, El-Khateeb BZ (2015) Simultaneous determination of naproxen and diphenhydramine by reversed phase liquid chromatography and derivative spectrophotometry. Der Pharma Chem 7(12):181–191

    CAS  Google Scholar 

  29. Maggio RM, Rivero MA, Kaufman TS (2013) Simultaneous acquisition of the dissolution curves of two active ingredients in a binary pharmaceutical association, employing an on-line circulation system and chemometrics-assistance. J Pharm Biomed Anal 72:51–58. https://doi.org/10.1016/j.jpba.2012.09.022

    Article  CAS  PubMed  Google Scholar 

  30. Nalluri BN, Mrudula B, Chitralatha K et al (2015) Development of stability indicating RP-HPLC-PDA method for the simultaneous analysis of naproxen sodium and diphenhydramine hydrochloride in bulk and tablet dosage forms. Indian Drugs 52:9

    Google Scholar 

  31. Ragab MAA, El Yazbi FA, Hassan EM et al (2018) Spectrophotometric analysis of two eye preparations, vial and drops, containing ketorolac tromethamine and phenylephrine hydrochloride binary mixture and their ternary mixture with chlorpheniramine maleate. Bull Fac Pharm Cairo Univ 56:91–100. https://doi.org/10.1016/j.bfopcu.2018.03.004

    Article  Google Scholar 

  32. Riad SM, El-Rahman MKA, Fawaz EM, Shehata MA (2015) A comparative study between three stability indicating spectrophotometric methods for the determination of diatrizoate sodium in presence of its cytotoxic degradation product based on two-wavelength selection. Spectrochim Acta Part A Mol Biomol Spectrosc 145:254–259. https://doi.org/10.1016/j.saa.2015.03.030

    Article  CAS  Google Scholar 

  33. Saad AS (2015) Novel spectrophotometric method for selective determination of compounds in ternary mixtures (dual wavelength in ratio spectra). Spectrochim Acta Part A Mol Biomol Spectrosc 147:257–261. https://doi.org/10.1016/J.SAA.2015.03.095

    Article  CAS  Google Scholar 

  34. Salinas F (1990) A new spectrophotometric method for quantitative multicomponent analysis resolution of mixtures of salicylic and salicyluric acids. Talanta 37:347–351. https://doi.org/10.1016/0039-9140(90)80065-N

    Article  CAS  PubMed  Google Scholar 

  35. Shehata MA, Fawaz EM, El-Rahman MKA, Abdel-Moety EM (2017) Double-track electrochemical green approach for simultaneous dissolution profiling of naproxen sodium and diphenhydramine hydrochloride. J Pharm Biomed Anal. https://doi.org/10.1016/j.jpba.2017.08.041

    Article  PubMed  Google Scholar 

  36. USP (2011) The United States Pharmacopeia and National Formulary, the Official Compendia of Standards, 4th edn. The United States Pharmacopeial Convention Inc., Rockville, p 2531

  37. Uysal Ü, Tunçel M (2004) Determination of naproxen in tablets by using first derivative potentiometry. Prostaglandins 1:217–223

    CAS  Google Scholar 

  38. Welch CJ, Wu N, Biba M et al (2010) Greening analytical chromatography. TrAC Trends Anal Chem 29:667–680

    Article  CAS  Google Scholar 

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Correspondence to Esraa M. Fawaz.

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Abou Al-Alamein, A.M., Abd El-Rahman, M.K., Fawaz, E.M. et al. UV-spectrophotometry versus HPLC–PDA for dual-drug dissolution profiling: which technique provides a closer step towards green biowaiver concept? Novel application on the recent FDA-approved mixture Aleve pm. Chem. Pap. 73, 309–319 (2019). https://doi.org/10.1007/s11696-018-0580-x

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Keywords

  • Naproxen
  • Diphenhydramine
  • UV-spectrophotometry
  • Ratio difference
  • HPLC–PDA
  • Dissolution
  • Biowaiver
  • Green analytical chemistry