Development and Validation for Determination of Apremilast in Bulk and in Tablets by UV Spectrophotometer

Abstract

Background: Pharmaceutical analysis plays a key role in the quality assurance and quality control of bulk drugs.
A documented validation program offers a high level of confidence that an operation or facility will consistently
deliver a product that satisfies a set standard. A premilast is an aphosphodiesterase-4 inhibitor used in the
treatment of psoriasis. Objective: The main objective is to develop a simple, rapid, accurate, and economical
spectrophotometric method for the determination of apremilast in bulk and its tablet dosage form as per ICH
guidelines. Materials and Method: The estimation was carried out using HPLC-grade acetonitrile as a solvent
and quantitation was achieved using a double-beam UV spectrophotometer at 230 nm. The present method was
suitable for its intended purpose as prescribed in ICH Q2 guidelines. The analytical method was validated to
determine the linearity, precision, accuracy, robustness, ruggedness, LOD, and LOQ of the method. Results: The
λmax of apremilast in acetonitrile was found to be 230 nm. The drug has a correlation coefficient (r2) value of
0.999 and exhibits linearity in the concentration range of 2–10 μg/mL. The proposed method was applied to
pharmaceutical formulation and % the amount of drug estimated 99% was found in good agreement with the label
claim. The repeatability, intraday, and interday changes of accuracy were examined. The approach is considered
exact if the percentage RSD value is <2. Conclusion: The above method was a rapid and cost-effective quality
control tool for routine analysis of apremilast in bulk and in pharmaceutical dosage form. The method can be useful
for the day-to-day routine analysis in the quality control departments of bulk and pharmaceutical formulations
industries.