HPLC-ELSD DETERMINATION OF SODIUM LAURYL SULPHATE AND POLYSORBATE IN NEBIVOLOL DRUG PRODUCT AND DIFFERENT FORMULATION PRODUCTS

The contents of Sodium lauryl sulphate (SLS) and Polysorbate (Tween 80) were studied in different formulations of Nebivolol film coated tablets. The contents were extracted using the diluent Methanol: Water in the ratio 60:40 v/v and analyzed in HPLC coupled with Evaporative light scattering detector (ELSD). SLS and Tween 80 are solubilizing agents and the amount of these contents are critical in formulations as they are play a major role in the release pattern of the drug for in-vivo and in-vitro dissolution profiles. A reverse phase liquid chromatographic (RP-LC) method was developed for the quantification of Sodium lauryl sulphate (SLS) and Polysorbate (Tween 80). The method was optimized using buffer (prepared by dissolving 0.77g of Ammonium acetate taken in 2000mL milli-Q-water and then pH was adjusted to 4.5with dilute acetic acid solution) as mobile phase-A and Acetonitrile mobile phase-B. The flow rate was set at 1.0 mL min-1 and the column temperature was maintained at 40°C. The capability of specific method developed was demonstrated by studying the validation parameters like interferences of other sample matrix, limit of quantification, limit of detection, linearity, method precision, accuracy and robustness as per ICH. The developed method can be used for the determination of SLS and Polysorbate 80 in the regular quality control analysis for the drug product