RP-HPLC Method Development and Validation of Choline Salicylate and Lignocaine HCl in Mouth Ulcer Gel

Objectives

The prime intent of the current study is to develop a rapid, reliable, robust and cost-effective reversed-phase HPLC method for simultaneous estimation of Choline Salicylate and Lignocaine HCl in mouth Ulcer Gel.

Materials and Methods

Buffer was prepared with 3.5 g of disodium hydrogen orthophosphate in 1000 mL of water and adjusted to pH 4.5 with dilute orthophosphoric acid. A mixture of Buffer and Methanol (55:45) containing 0.01M (2.062 g) 1-Hexane Sulphonic acid comprised the mobile phase. The separation was carried out with a Hypersil C₁₈ column (250x4.6 mm, 5 μ) maintained at a temperature of 30°C at a flow rate of 1.0 mL/min with detection at 220 nm. The Injection volume was 20 μL and the run time was 20 min.

Results

Retention time for choline salicylate and Lignocaine HCl was 3.163 and 9.629 min respectively. Linearity for Choline Salicylate and Lignocaine Hydrochloride was found to be in the range of 12.5-50 μg/mL. The correlation coefficient for the linear curve obtained between concentration vs. area for standard preparations of Choline Salicylate and Lignocaine HCl was 0.9992 and 0.9993 respectively. The projected procedure successfully satisfied the specificity and robustness parameters.

Conclusion

The analytical method was successfully validated according to ICH guidelines (ICH, Q2 (R1)). The proposed novel method is reliable and cost-effective and is well-suited for use in the pharmaceutical industry.