SENSITIVE SPECTROPHOTOMETRIC DETERMINATION OF ACETYLCHOLINESTRASE INHIBITOR DONEPEZIL HYDROCHLORIDE IN PURE FORM AND PHARMACEUTICAL FORMULATIONS USING SULPHONPHETHALIN DYES
Keywords:Donepezil hydrochloride, Spectrophotometry, Ion-pair complex, Sulphonphthalein dyes, Pharmaceutical formulations
Objective: Four sensitive, selective, rapid, validated and easily reproducible spectrophotometric methods have been developed for the determination of acetylcholinesterase inhibitor donepezil hydrochloride (DNP) in pure form and in pharmaceutical formulations
Methods: The proposed methods are based on ion-pair complex formation between donepezil hydrochloride with four acidic (sulphonphthalein) dyes; namely bromocresol green (BCG), bromothymol blue (BTB), bromophenol blue (BPB) and bromocresol purple (BCP) which extracted into dichloromethane followed by the measurement of the yellow colored ion-pair complexes at 420, 413, 415 and 409 nm for DNP-BCG, DNP-BTB, DNP-BPB and DNP-BCP complexes, respectively.
Results: Beer's law was obeyed in the concentration ranges of 1.0-12 and 1.0-10 Î¼g ml-1for (BCG or BCP) and (BTB or BPB) methods, respectively with limits of detection (LOD) of 0.16, 0.24, 0.19 and 0.25 Î¼g/ml using BCG, BCP, BTB and BPB methods, respectively. The stoichiometry of the ion-pair complex formed between the dug and dye found to be (1:1) was determined by Job's method of continuous variations. Various analytical parameters have been evaluated and the results have been validated by statistical data.
Conclusion: The proposed methods were validated in accordance with ICH guidelines and successfully applied to the determination of donepezil hydrochloride in pure and dosage forms. Statistical comparison of the results obtained by applying the proposed methods with those of the reported method revealed good agreement and proved that there was no significant difference in the accuracy and precision between the results.
Sweetman S. Martindale, The Complete Drug Reference. 37th Edition. The Pharmaceutical Press; London; 2011; Electronic version; 2002;32:1417.
Bryson M and Benfield P. Donepezil new drug profile. Drugs Aging 1997;10:234-9.
Winblad B, Kilander L, Eriksson S, Minthon L, Batsman S, Wetterholm AL, et al. Donepezil in patients with severe Alzheimer's disease: Double-blind, parallel-group, placebo-controlled study. Lancet 2006;367:1057.
Nakashima K, Itoh K, Kono M, Nakashima MN, Wada M. Determination of donepezil hydrochloride in human and rat plasma, blood and brain microdialysates by HPLC with a short C 30 column. J Pharm Biomed Anal 2006;41:201-6.
Iordachescu A, Silvestro L, Tudoroniu A, Rizea Savu S, Ciuca V. LCâ€“MSâ€“MS Method for the Simultaneous Determination of Donepezil Enantiomers in Plasma. Chromatographia 2012;75:857-64.
Mallu UR, Reddy KH, Bobbarala V, Penumajji S. RP-HPLC method development for the determination of assay of donepezil hydrochloride. Int J Chem Anal Sci 2010;1:35-6.
Liew KB, Peh KK, Fung Tan YT. RP-HPLC analytical method development and optimization for quantification of donepezil hydrochloride in orally disintegrating tablet. Pak J Pharm Sci 2013;26:961-6.
Abonassif MA, Hefnawy MM, Kassem MG, Mostafa GA. Determination of donepezil hydrochloride in human plasma and pharmaceutical formulations by HPLC with fluorescence detection. Acta Pharm 2011;61:403-13.
Kafkala S, Matthaiou S, Alexaki P, Abatzis M, Bartzeliotis A, Katsiabani M. New gradient high-performance liquid chromatography method for determination of donepezil hydrochloride assay and impurities content in oral pharmaceutical formulation. J Chromatogr A 2008;1189:392-7.
Gotti R, Cavrini V, Pomponio R, Andrisano V. Analysis and enantioresolution of donepezil by capillary electrophoresis. J Pharm Biomed Anal 2001;24:863-70.
Lu YH, Zhang M, Meng Q, Zhang ZX. Separation and determination of donepezil hydrochloride enantiomers in plasma by capillary electrophoresis. Yaoxue Xuebao 2006;41:471-5.
Mostafa GA, Hefnawy M, Al-Majed A. Membrane sensors for the selective determination of donepezil hydrochloride. J AOAC Int 2010;93:549-55.
Abbas SS, Fayez YM, Abdel Fattah Lel-S. Stability indicating methods for determination of donepezil hydrochloride according to ICH guidelines. Chem Pharm Bull 2006;54:1447-50.
Jayanna BK, Nagendrappa G, Ninge Gowda A. A facile spectrophotometric method for the determination of donepezil hydrochloride in tablets formulation using potassium permanganate. Asian J Pharm Biol Res 2012;2:216-18.
Ravi Kumar V, Chaitanya S, Sambasiva Rao A, Sreekiran M. Estimation of donepezil hydrochloride by ion complex extractive spectrometry. Int J Res Pharm Chem 2011;1:512-8.
Shirwaikar A, Devi S, Rajagopal PL, Kiron SS, Sreejith KR. Ion pair extraction method for determination of donepezil hydrochloride in pure and dosage forms. Int J Res Pharm Biomed Sci 2013;4:1386-93.
Sangsetti JN, Mahaparale PR, Paramane S, Sinde DB. Spectrophotometric estimation of donepezil hydrochloride in bulk and tablet formulation. Trends Appl Sci Res 2008;3:109-12.
Sreejeth KR, Siju EN. Spectrophotometric method for the analysis of donepezil hydrochloride. Indian Pharm 2010;9:67-70.
Venkatrao1 SV, Malleswararao1 NNV, Sivaramakrishna1 V, Neeharika T, Rambabu C. Simple and sensitive extractive spectrophotometric method for the assay of Donepezil HCl in pure and Pharmaceutical formulations. J Pharm Res 2012;5:3527-9.
Pillai S, Singhvi I. Application of orange dye for quantitation of donepezil hydrochloride from tablet formulation. Indian J Pharm Sci 2006;68:682-4.
Shirwaikar A, Devi S, Rajagopal PL, Kiron SS, Sreejith KR. Development and validation of analytical method for determination of donepezil hydrochloride in pure and dosage forms. Asian J Pharm Clin Res 2014;7:149-53.
Raghubabu K, Santhi Swarup L, Kalyana Ramu B, Rupakumari G, Narayanarao M, Ramdas C. Development and validated visible Spectrophotometric methods for the assay of donepezil hydrochloride in pharmaceutical preparations. Res J Pharm Tech 2012;5:228-32.
Gouda AA, El Sheikh R, El Saied H. Extractive spectrophotometric determination of azelastine hydrochloride in pure form and pharmaceutical formulations. Can Chem Trans 2015;3:29-41.
El Sheikh R, Zaky M, Gouda AA, Abo Al Ezz S. Extractive spectrophotometric determination of vardenafil HCl and yohimbine HCl in pure and pharmaceutical dosage forms. J Chil Chem Soc 2014;59:2248-55.
Shoaibi ZA, Gouda AA. Extractive spectrophotometric method for the determination of tropicamideâ€. J Young Pharm 2012;4:42-8â€.
El Sheikh R, Esmail NS, Gouda AA, Basset WA. Extractive spectrophotometric determination of some Î±-adrenergic-antagonists in pure forms and in pharmaceutical formulations. Chem Ind Chem Eng Q 2012;18:179-91â€.
Alkaf A, Gouda AA. Spectrophotometric determination of tadalafil in pure and dosage formsâ€. Chem Ind Chem Eng Q 2011;17:125-32â€.
Gouda AA, Shafey ZE, Hossny N, El-Azzazyâ€ R. Spectrophotometric determination of hyoscine butylbromide and famciclovir in pure form and in pharmaceutical formulations. Spectrochim Acta A 2008;70:785-92.
â€Hassan WS, El-Henawee MM, Gouda AA. Spectrophotometric determination of some histamine H1-antagonists drugs in their pharmaceutical preparationsâ€, Spectrochim Acta A 2008;69:245-55.â€
Amin AS, Gouda AA, El-Sheikh R, Zahran F. Spectrophotometric determination of gatifloxacin in pure form and in pharmaceutical formulation. Spectrochim Acta A 2007;66:1306â€“12.
El-Sheikh R, Zaky M, Mohamed FZ, Amin AS, Gouda AAEF. Spectrophotometric determination of dextromethorphan hydrobromide and ketamine hydrochloride in pure and dosage forms. J Chin Chem Soc 2006;53:831-8.
Scorpio R. "Fundamentals of Acids, Bases, Buffers & Their Application to Biochemical Systems"; 2000.
Job P. "Spectrochemical Methods of Analysis", Wiley Intersience: New York; 1971. p. 346.
Skoog DA, West DM, Holler FJ. "Fundamentals of analytical chemistry". 7th Ed. Saunders: College Publishing, Philadelphia; 1996.
H. IC, November ICH. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, Q2(R 1), Complementary Guideline on Methodology dated 06 London. 2005;1996.
Miller JN, Miller JC. Statistics and chemometrics for analytical chemistryâ€. 5th ed. Prentice Hall, England; 2005.