Analytical Method Validation for Related Substances of Carbocisteine Syrup 250mg/5ml BY HPLC

Abstract

The objective of this study is to validate the HPLC method to be used for the determination of related substances of Carbocisteine syrup 250mg/5ml by HPLC.

Introduction: Carbocisteine syrup is used to treat respiratory conditions with thick mucus, brochitis, cystic fibrosis and COPD (Chronic Obstructive Pulmonary Disease).

Materials and Methods: Waters HPLC Model no. 2695, HPLC Column: Lichrosphere-100 NH2, 250 mm x 4.6 mm, 5-μm was used with Mobile phase Buffer and Acetonitrile in the ratio of 570:430%v/v.

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 Carbocisteine Syrup 250mg/5ml 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 Carbocisteine specification level and can be used for intended purpose.