Analytical Method Validation for Related Substances of Dicycloverine Tablets 10 mg, 20 mg by HPLC
Keywords:
HPLC, dicycloverine, irritable bowel syndrome (IBS).Abstract
The objective of this study is to validate the HPLC method to be used for the determination of related substances of Dicycloverine Tablets 10 mg and 20 mg by HPLC.
Introduction: A dicycloverine tablet is an anticholinergic antispasmodic medication used to relieve cramps, pain, and spasms in the stomach and intestines, commonly for conditions like irritable bowel syndrome (IBS) by relaxing gut muscles.
Materials and Methods: Waters HPLC Model no. 2695, Agilent HPLC Model no.1100, HPLC Column: Inertsil ODS-3V, 250 mm x 4.6 mm, 5-μm was used with Mix mobile phases of Mobile phase A: ammonium acetate solution in water and Mobile Phase B: Methanol.
Results and Discussion: System precision and System suitability, Specificity, Limit of Detection (DL) & Limit of Quantitation (QL), Precision at QL, Method precision, Linearity, Accuracy, Range, Intermediate Precision and Robustness were evaluated.
Conclusion: The HPLC method for Related substances of Dicycloverine Tablets 10 mg and 20 mg has been validated. The test method was found to be specific, precise, linear and accurate in the range of QL (Limit of Quantitation) to 200% of Dicycloverine specification level and can be used for intended purpose.
