ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF DICYCLOMINE HYDROCHLORIDE AND DICLOFENAC POTASSIUM BY UHPLC IN SOLID DOSAGE FORMS

Srivijay R.*, Vijayamirtharaj R. and Senthil Kumar N.

ABSTRACT

In pharmaceutical dosage forms, a new UHPLC method was developed and validated to simultaneously estimate Diclofenac Potassium and Dicyclomine Hydrochloride. By utilizing UHPLC, this method fills a gap in the existing literature. Optimizing various parameters of the chromatographic process was key to developing an effective method for separating and detecting drugs. International guidelines and regulatory requirements were followed for the validation of the method, including specificity, linearity, accuracy, precision, robustness, and suitability for the system. For the injection and analysis of mixed solutions containing Dicyclomine HCl and Diclofenac potassium, a Chromatographic separation was achieved on a Kromasil C18 (4.6 mm × 250 mm), 5μm.a mobile phase ratio consisting of (35:65) Water: Methanol at flow rate 1.0 ml/min, and total run time 8min, The injection volume 20μl. The detection wavelength is 263 nm. Approximately 2000 plates were found, indicating a successful chromatographic separation. With a tailing factor of less than 2 and a well-resolved peak, the peaks appear symmetrical and well-resolved. In order to ensure there were no interfering peaks, the retention times for Dicyclomine Hydrochloride and Diclofenac Potassium were found to be 2.745 min and 3.341min.As for Dicyclomine Hydrochloride, the correlation coefficient (R2) is 0.9999 and Diclofenac Potassium is 0.9999. This indicates a good linear relationship between drug concentrations and peak areas based on the high correlation coefficients. For Dicyclomine Hydrochloride and Diclofenac Potassium, the %RSD values were 0.87% and 1.08%, respectively, below the acceptable limit of 2%. As a result, the method is accurate and repeatable. In the study of Dicyclomine Hydrochloride, the mean percent recovery was 98.37%, while in the study of Diclofenac Potassium, the mean percent recovery was 98.31%, while the mean percent recovery was 100.34%.Under varied conditions, both Dicyclomine Hydrochloride and Diclofenac Potassium showed %RSD values within the acceptable range of 2%, demonstrating the robustness and reliability of the method. This study concluded that valuable insight is provided into the use of validated UHPLC methods in this study, which contributes significantly to the evolution of pharmaceutical analytical techniques.

Keywords: Diclofenac Potassium, Dicyclomine Hydrochloride, UHPLC, Chromatography, Method validation.