ICH Q2 (R2)-Compliant Development and Validation of a Stability-Indicating First-Order Derivative UV-Visible Spectrophotometric Method for Tenofovir Disoproxil

We aimed to develop a stability-indicating method for tenofovir disoproxil using first-order derivative UV spectrophotometry to achieve clearer separation of overlapping spectra and ensure reliable detection of the drug along with its degradation products. λmax was recorded at 231 nm, while the first-order derivative wavelength was selected at 244 nm. The method followed Beer–Lambert’s law in the concentration range of 35–60 µg/mL with an R2 = 0.9961, and methanol proved to be the most suitable solvent. The method was validated as per ICH Q2 (R2) guidelines, covering linearity, accuracy, precision, LOD, LOQ, and robustness. The results showed minimal variation, with RSD values below 2%, and a recovery range of 98–101%, confirming the method’s accuracy. Forced degradation studies under different stress conditions further demonstrated the stability of tenofovir disoproxil, supporting its reliability during formulation and market release. Thus, the method provides a dependable, precise, and economical analytical strategy for assessing the stability profile of tenofovir disoproxil and identifying its degradation products.

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