• P. Vivek Sagar Department of Pharmaceutical Analysis Care College of pharmacy, Oglapur (v), Atmakur (M), Warangal Telangana, India
  • Nelofer Bagum Department of Pharmaceutical Analysis Care College of pharmacy, Oglapur (v), Atmakur (M), Warangal, Telangana, India
  • S. Shobha Rani Department of Pharmaceutical Analysis Jawaharlal Nehru Technological University, Kukatpally, Hyderabad, Telangana, India.


Armodafinil, RP HPLC, Stability indicating assay, Validation


Objective: To develop simple reverse phase HPLC method for the estimation of Armodafinil in tablet dosage form.

Methods: Chromatography was performed by isocratic elution on a Stainless steel Hibar C18 column with dimensions 4.6 x 250 mm, packed with octadecylsilane bonded to porous silica (C18) with particle size 5 micron. Acetonitrile and water in the ratio of 50:50 v/v is used as mobile phase. The flow rate is 1.0 ml/ min and effluent is monitored at 220 nm. Armodafinil was eluted at a retention time of 3.8 minutes.

Results: The standard curve of Armodafinil was linear over a working range of 1–700 µg/ml and gave an average correlation coefficient of 0.999. The limit of quantitation (LOQ) of the drug is 0.1 µg/ ml. Recovery studies were carried out by standard addition method and the recoveries are found satisfactory within the range of 99.3 to 101.5 %. The method is precise with % RSD below

Conclusion: The method is validated in terms of robustness and forced degradation studies were carried out and this method can be applied for routine degradation studies ans quantification in regular laboratories.


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Quezia B Cass, Cristiane K Kohn, Silvana A Calafatti, Hassan Y

Aboul-Enein. An enantioselective assay for (±)-modafinil. J

Pharm and Biomed Ana 2001;26(1):123-30.

Jennifer L, Robert J, John S, DeVane C. Donovan, Malcolm,

Markowitz, Lindsay. Chiral Analysis of d-and l-Modafinil in

Human Serum:Application to Human Pharmacokinetic Studies.

J Ther Drug Monit 2003;25(2):197-202.

Cass QB, Ferreira Galatti T. A method for determination of the

plasma levels of modafinil enantiomers, (+/-)-modafinic acid

and modafinil sulphone by direct human plasma injection and

bidimensional achiral-chiral chromatography. J Pharm Biomed

Anal 2008;46(5):937-44.

Khaldun M, L A, Rohana B. Muhammad IdirisSaleh. Enantios

elective determination of modafinil in pharmaceutical

formulations by capillary electrophoresis and computational

calculation of their inclusion complexes. J Mic Chim Acta


Suyun W. Wei Xiaojuan Zhou, YibingJi and Bingren Xiang.

Enantiomeric Separation and Determination of the

Enantiomeric Impurity of Armodafinil by Capillary

Electrophoresis with Sulfobutyl Ethercyclodextrin as Chiral

Selector. J Molecules 2012;17(1):303-14.

New LC, S M Ramesh, Devi; Ramakrishna, Singirikonda;

Habibuddin, Mohammad. Development and Validation of

MS/for the Determination of armodafinil in Human Plasma. J

Current Pharm Ana 2012;8(3):295-305.

H. IC. Validation of analytical procedure: Methodology Q2B,

Tripartite Guidelines. J Pharm Biomed Anal 1996.

ICH harmonized tripartite guideline. Impurities in New Drug

products Q3B R2 current step 4 versions dated 2 June 2006.

H. IC. Guideline, Validation of analytical procedures:Text and

Methodology Q2 (R1);November. J Pharm Biomed Anal 2005.



How to Cite

Sagar, P. V., N. Bagum, and S. S. Rani. “STABILITY INDICATING RP HPLC METHOD FOR THE ESTIMATION OF ARMODAFINIL IN TABLET DOSAGE FORM”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 6, no. 8, Aug. 2014, pp. 604-9,



Original Article(s)