REVIEW ON METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DICYCLOMINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM
Garamsandh Gandhi V.*, Kamalakannan Dhanabalan, Manivannan R., Gokul M., Pragatheswaran S., Sangeetha V. S. and Surendar K.
ABSTRACT
This study presents the development and validation of a simple, accurate, precise, and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative determination of Dicyclomine Hydrochloride in pharmaceutical dosage forms. Unlike previous studies, which did not explore on Dicyclomine Hydrochloride Capsule, chromatographic separation was achieved using an HPLC system (Waters with Empower2 software) with a Phenomex C18 (250 x 4.6 mm, 5 µm) column. The mobile phase consisted of a 60:40 v/v mixture of Acetonitrile And Triethylamine, adjusted to pH 3.0 with ortho phosphoric acid. The method operated at a flow rate of 0.9 mL/min, with the column maintained at ambient temperature, and detection occurred at 218 nm using a UV-Visible Detector. Dicyclomine Hydrochloride were effectively resolved with retention times of 4.4 minutes, respectively. The method demonstrated linearity within the concentration range of 2-12 μg/mL, with a correlation coefficient (r²) of 0.999. The method was validated for stability under forced degradation conditions, confirming its suitability for routine pharmaceutical analysis.
Keywords: Dicyclomine HCL, RP-HPLC, HPLC, UV-Spectroscopy.
[Full Text Article]
[Download Certificate]
Impact Factor : 8.181 
