European Journal of Biomedical and Pharmaceutical Sciences

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR CLOMIPHENE CITRATE IN TABLET DOSAGE FORM

Ritesh D. Rode*, Ankit R. Pawar, Vinit R. Patil, Namrata B. Pawar, Swati A. Kamble, Snehal D. Patil, Amit N. Panaskar, Bhagyashri A. Panaskar

ABSTRACT

A simple, rapid, accurate, precise, and cost-effective UV spectrophotometric method was developed and validated for the estimation of Clomiphene Citrate in tablet dosage form. Clomiphene Citrate exhibited maximum absorbance (λ max) at 244 nm using Methanol: Water (50:50 v/v) as the solvent system. The developed method obeyed Beer–Lambert’s law in the concentration range of 10–50 µg/mL with good linearity. The calibration curve showed a regression equation of y = 0.001x + 0.0432 with a correlation coefficient (R²) of 0.9972. The developed analytical method was validated according to ICH guidelines with respect to parameters such as linearity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). The %RSD values obtained for intra-day and inter-day precision studies were found to be less than 5%, indicating good precision of the method. Accuracy studies were carried out by recovery studies at 50%, 100%, and 150% levels, and the average recovery was found to be 100.78%, confirming the accuracy of the method. The LOD and LOQ values were found to be 3.18 µg/mL and 9.66 µg/mL, respectively. The developed method was found to be simple, sensitive, reliable, and suitable for routine quality control analysis of Clomiphene Citrate in pharmaceutical tablet formulations.

Keywords: Clomiphene Citrate, UV Spectrophotometry, Method Validation, Tablet Dosage Form, ICH Guidelines.