RP-HPLC method development and validation for estimation of dicyclomine hydrochloride in its Bulk and Drops Form Rao Nutan*, Desai Akshata Department of Quality Assurance, Oriental College of Pharmacy, Sector 2, Sanpada West, Navi Mumbai, Maharashtra, India. *Corresponding Author E-mail: nutan.rao@ocp.edu.in
Online published on 30 April, 2021. Abstract A simple, precise, accurate and rapid Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed for estimation of Dicyclomine hydrochloride. Detection was carried out at 218nm using UV-visible detector. Chromatographic separation of the drug was carried on Shimadzu shim-pack GIST C18 (250mmX4.6mm, 5μm) column using mobile phase as a mixture of Acetonitrile and Buffer pH5.9 in the ratio of 70: 30 at 1.0ml/min flow rate. The Retention time for dicyclomine HCL was found to be 4.4 minutes. The calibration curve was found to be linear over a concentration range of 50–150μg/ml with correlation coefficient of 0.997 at selected wavelength. The percentage RSD was found to be less than 2% for Accuracy and Precision of the method. This method was validated using parameters such as linearity, accuracy, precision, robustness, specificity, system suitability and solution stability. It can be concluded that the proposed method can be effectively used for estimation of Dicyclomine hydrochloride in pure form as well as in pharmaceutical formulations. Top Keywords Dicyclomine hydrochloride, HPLC, Method development, Validation, Analysis. Top |