World Journal of
Pharmaceutical and Life Sciences

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR ANTIPSYCOTIC DRUG

Tanaya S. Bahadure*, Sakshi G. Kancharlawar, Rohan S. Chavhan, Ajinkya V. Gulhane and Dr. Manisha D. Kitukale

ABSTRACT

The present research outlines the development and validation of a UV-visible spectrophotometric method for the quantitative estimation of Venlafaxine Hydrochloride, an antipsychotic and antidepressant agent. The method was designed to be simple, rapid, accurate, precise, and economical, making it suitable for routine quality control applications in pharmaceutical industries. Venlafaxine Hydrochloride exhibited a maximum absorbance (λmax) at 223 nm when dissolved in 0.1 N NaOH, which was identified as the most suitable solvent based on solubility and spectral stability. The method demonstrated excellent linearity in the concentration range of 5–25 μg/mL with a correlation coefficient (r²) of 0.9968. Validation parameters, including accuracy (98.5%–101.2% recovery), precision (%RSD < 2), specificity, robustness, and sensitivity (LOD: 0.267 μg/mL; LOQ: 0.810 μg/mL), complied with ICH Q2(R1) guidelines. The proposed method was successfully applied for the estimation of Venlafaxine Hydrochloride in commercial tablet formulations, showing consistent results within pharmacopeial limits. This validated method offers a reliable analytical tool for the routine assessment of Venlafaxine Hydrochloride in bulk and finished dosage forms.

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