Development and Validation of UV-Spectrophotometric and RP-UHPLC Method for the Determination of Clomiphene Citrate in Bulk Drug and Tablet Dosage Form

In this study, we explore the potential of clomiphene citrate, a selective estrogen receptor modulator (SERM) and ovulatory stimulant, by developing UV-Spectrophotometric and RP-UHPLC methods. These innovative techniques offer precise and reliable means of determining clomiphene citrate levels in both bulk drug and tablet formulations. UV-Spectrophotometric method was developed employing Analytical Technology Limited and to achieve exceptional chromatographic separation of components, we employed an advanced Agilent tech. gradient system equipped with an auto-injector and DAD detector. A Reverse Phase C18 (100 mm x 4.6mm; 2.5µm) column served as the stationary phase, while a unique mobile phase consisting of methanol and 0.1% OPA water (50:50% v/v) further enhanced the efficiency. In adherence to the rigorous guidelines of the International Conference on Harmonization (ICH), we thoroughly validated both the UV and RP-UHPLC methods. The UV-Spectrophotometric analysis of clomiphene citrate reveals an astonishing maximum absorbance at 234nm, utilizing water: methanol (90:10) solvent blend. The entire process of RP-UHPC with a flow rate of 1.0ml/min meticulously monitored the absorbance at 234nm, successfully eluting clomiphene citrate at an astonishingly rapid rate of 2.9 minutes. The validation parameters, including linearity, accuracy, precision, system suitability, detection limit, quantitation limit, robustness, and ruggedness, all demonstrated exceptional performance, well within the acceptance limits. For the UV method, a remarkable linearity range emerged, spanning concentrations from 5-25µg/ml, boasting an impressive R² value of 0.9998. Meanwhile, the RP-UHPLC method exhibited a linearity range from 2.5-12.5μg/ml, showcasing an astounding R² value of 0.9991.This developed method revolutionizes the determination and quantification of clomiphene citrate in bulk drug and tablet formulations. The remarkable precision and reliability of our UV-Spectrophotometric and RP-UHPLC methods promise to elevate the understanding and application of clomiphene citrate to unprecedented heights.