Development and Validation of an Analytical Method for Determination of Modafinil in Bulk and Formulations using First Order Derivative UV Spectrophotometer

Abstract

Analytical method validation is an important tool to determine the absolute concentration of drug in the formulation. In the case where a drug is not able to produce characteristic peak shape, a simple, accurate, precise and sensitive method, which will be governed through the software conversion of UV spectra into the first-order derivative, can be used as an alternative method for the estimation of modafinil in bulk and pharmaceutical dosage forms. Modafinil, estimated at 232 nm at which its first-order derivative curve gives a characteristic peak shape in ACN: water (35:65). The method was evaluated and found to be linear (obeys Beer’s law) in the defined concentration range of 2.5‑20 mcg/ml. According to ICH Q2 R1, the validation of the developed method was proceeded and was found to be accurate and precise. Thus, the proposed method can be successfully applied for the estimation of modafinil in relevant dosage forms.

Keywords: first-order derivative, ICH Q2 (R1) validation, linear regression value, Modafinil, spectrophotometer

Cite this Article

Hemal Tandel, Dhaval Shah, Nilima Pandya, Ambikanandan Misra. Development and Validation of an Analytical Method for Determination of Modafinil in Bulk and Formulations using First Order Derivative UV Spectrophotometer. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2019; 6(3): 23–29p.