Development and validation of stability indicating method for determination of sodium citrate in pediatric cough syrup

Abstract

Sodium Citrate is widely used in analytical and food processes. It is used in various medical applications as anticoagulant in blood transfusion process and bladder washout. It is used in cough preparation as mucolytic. There are many methods for determination of Sodium Citrate in different preparations. Some of which use spectrophotometric methods, others used HPLC methods. The USP method uses titration and determining the end point potentionometrically. Many arguments take place between the Drug Regulatory Affairs and manufacturers regarding the appearance of the colour at the end point. The objective of this study is to develop and validate a simple, easy and precise HPLC stability indicating method for routine work and to be submitted to the Drug Regulatory Affairs. Chromatographic system with detector PDA at 210nm is utilized, Reprosil-XR C18, 250 mm×4 mm, 5 µm column is used. Column temperature 300C and flow rate of 1 ml/min. A clear peak of acceptable purity at 3.38 min retention time appears. The method is subjected to thermal stress, acid and base hydrolysis at extreme pH and forced oxidation. The result is that there is no interference of degradation products with the substance peak. The method is then subjected to validation study according to the ICH guidelines. The method comply the specificity, precision, linearity, accuracy and robustness acceptable criteria. Thus, the method satisfies the stability indicating method and validation requirements that it can be submitted to the Drug Regulatory Affairs and used in QC routine activities and stability studies.