Malaysian Journal of Analytical Sciences Vol 18 No 2 (2014): 329 – 366

 

 

 

DETERMINATION OF MODAFINIL IN TABLET FORMULATION USING THREE NEW VALIDATED SPECTROPHOTOMETRIC METHODS

 

(Penentuan Modafinil Dalam Formulasi Tablet Menggunakan Tiga Kaedah Spektofotometrik Ditentusahkan)

 

Pawan Kumar Basniwal^1,2* and Deepti Jain¹

 

¹School of Pharmaceutical Sciences,

Rajiv Gandhi Technological University, Bhopal – 462033, Madhya Pradesh, India

² LBS College of Pharmacy, Jaipur – 302004, Rajasthan, India

 

*Corresponding author: pawanbasniwal@gmail.com

 

 

Abstract

In this study, three new UV spectrophotometric methods viz. linear regression equation (LRE), standard absorptivity (SA) and first order derivative (FOD) method were developed and validated for determination of modafinil in tablet form. The Beer-Lambert’s law was obeyed as linear in the range of 10-50 μg/mL and all the methods were validated for linearity, accuracy, precision and robustness. These methods were successfully applied for assay of modafinil drug content in tablets in the range of 100.20-100.42%, 100.11-100.58% and 100.25-100.34%, respectively with acceptable standard deviation (less than two) for all the methods. The validated spectrophotometric methods may be successfully applied for assay, dissolution studies, bio-equivalence studies as well as routine analysis in pharmaceutical industries.

 

Keywords: Modafinil, linear regression equation, standard absorptivity, first order derivative, tablets

 

Abstrak

Dalam kajian ini, tiga kaedah spektrofotometri UV baru iaitu persamaan regresi linear (LRE), daya penyerapan piawai (SA) dan terbitan tertib pertama (FOD) kaedah telah dibangunkan dan distentusahkan terhadap penentuan modafinil di dalam bentuk tablet. Hukum Beer-Lambert telah dipatuhi sebagai linear dalam julat kepekatan 10-50 μg/mL dan semua kaedah telah ditentusahkan tehadap kelinearan, ketepatan, kejituan dan keteguhan. Kaedah-kaedah ini telah berjaya diaplikasi bagi ujikaji kandungan dadah modafinil di dalam bentuk tablet iaitu masing – masing pada julat 100.20 – 100.42%, 100.11 – 100.58% dan 100.25-100.34%, dengan sisihan piawai yang boleh diterima (kurang dari dua) untuk semua kaedah. Kaedah spektrofotometri disahkan berjaya digunapakai terhadap ujikaji pelatutan, kajian bio-kesetaraan serta analisis rutin di dalam industri farmaseutikal.

 

Kata kunci: Modafinil, persamaan regresi linear, keberserapan standard, perintah pertama terbitan, tablet

 

References

1.       Keating, G.M., Raffin, M.J. (2005) Modafinil: a review of its use in excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome and shift work sleep disorder. CNS Drugs, 19(9): 785-803.

2.       Rao, N.R., Shinde, D.D., Talluri, M.V.N., Agawane, S.B., (2008). LC–ESI-MS determination and pharmacokinetics of adrafinil in rats. Journal of Chromatography B, 873: 119–123.

3.       Devadiga, M. P., Anandan, P., Mukhopadhyay, A. (2011). Development of a rapid and sensitive method for estimation of armodafinil in human plasma by LCMS/MS. International Journal of Applied Biology and Pharmaceutical Technology, 2(1): 323-327.

4.       Schwertnera, H. A., Kong, S. B. (2005). Determination of modafinil in plasma and urine by reversed phase high-performance liquid-chromatography. Journal of Pharmaceutical and Biomedical Analysis, 2005; 37, 475–479.

5.       Rao, N. R., Shinde, D.D., Kumar T.M.V. (2008). Enantioselective HPLC resolution of synthetic intermediates of armodafinil and related substances. Journal of Separation Science, 31(6-7): 981-989.

6.       Rao, N. R., Shinde, D.D., Ramesh, V., Srinivas, R. (2009). LC-MS of novel narcoepileptics and related substances. Journal of Separation Science, 32: 1312–1322.

7.       Wang, W., Xiang, S., Zhou, X., Ji, Y., Xiang, B. (2012). Enantiomeric separation and determination of the enantiomeric impurity of armodafinil by capillary electrophoresis with sulfobutyl ether--cyclodextrin as chiral selector. Molecules, 17: 303-314.

8.       Basniwal, P. K., Kumar, V., Shrivastava, P.K., Jain, D. (2010). Spectrophotometric determination of cilostazol in tablet dosage form. Tropical Journal of Pharmaceutical Research, 9(5): 499-503.

9.       Jain, D., Basniwal, P. K. (2013). Spectrophotometric determination of olopatadine hydrochloride in eye drops and tablets Journal of Pharmaceutical Research,12(2): 48-52.

10.    Text on Validation of Analytical Procedures. International conference on harmonization of technical requirements for registration of pharmaceutical for human use; Geneva; 2000.

11.    Validation of Analytical Procedure: Methodology; International conference on harmonization of technical requirements for registration of pharmaceutical for human Use; Geneva; 2000.