Abstract

*Unmesh Keshwar, Pranali Ingole, Sharad Dhurde and B. K. Shrikhande

ABSTRACT

Background: Most of the herbal formulations contain synthetic preservatives like potassium sorbate (PS) and sodium benzoate (SB) for preventing the microbiological contamination. Identification and quantification of these preservative is mandatory requirement with respect to quality and consumers safety. Hence Siddhayu Ayurvedic Research Foundation Pvt. Ltd. has developed and validated the method. Objective: Objective of the present study was to develop the method with good resolution for simultaneous estimation of potassium sorbate and sodium benzoate using RP-HPLC method from herbal syrup formulation and validate it. Methods: In this RP-HPLC method, an analytical C18 column was used to achieve simultaneous chromatographic separation by using Buffer solution: Acetonitrile: Tetrahydrofuran (80:10:10 v/v/v) as mobile phase at flow rate of 1.5 ml/min. Quantification was carried out using a photodiode array detector at 232 nm. This developed method was also validated according to International Conference on Harmonization guidelines. Results: The retention time of PS and SB was 10.93 and 13.95 minutes respectively with good resolution. The estimated amount of PS and SB was found to be 0.0993 % and 0.2014 % in the herbal syrup formulation. All the test results of the evaluated validation parameters were found well within the limits. Conclusion: The developed method is able to separate the potassium sorbate and sodium benzoate simultaneously with good resolution. Hence, the present analytical method is applicable for simultaneous determination of PS and SB in herbal syrup formulation. Also results obtained in validation parameters indicate the reliability of the developed simultaneous HPLC method.