The ANALYTICAL METHOD VALIDATION REPORT FOR SODIUM LAURYL SULPHATE (SLS) / Sodium Dodecyl Sulfate residue by HPLC was prepared to demonstrate that the method is suitable for cleaning validation residue analysis from stainless steel surfaces. The protocol describes the complete methodology, validation parameters, acceptance criteria, and execution plan required to prove that the method can accurately detect and quantify SLS residue after equipment cleaning.
The method uses Sodium Lauryl Sulphate standard, methanol, sodium perchlorate monohydrate, purified water, mobile phase, diluent, swabs, filters, and HPLC instrumentation. The mobile phase is prepared using buffer and methanol in the ratio of 200:800 v/v, while the diluent is prepared using water and methanol in the ratio of 70:30 v/v. The chromatographic conditions include an RP18 column, 45°C column oven temperature, 31°C RID temperature, 0.8 mL/min flow rate, 100 µL injection volume, 10-minute run time, and isocratic elution.
The protocol includes validation parameters such as system suitability, specificity, filter compatibility, precision, LOD, LOQ, linearity, accuracy, range, solution stability, and robustness. System suitability verifies instrument performance using standard injections by checking %RSD and tailing factor. Specificity confirms that blank and swab blank do not interfere at the SLS retention time. Filter compatibility evaluates nylon and PVDF syringe filters, with PVDF filter and suitable discard volume preferred for sample filtration.
Precision includes method precision, intermediate precision, and reproducibility to confirm consistent recovery under same and changed conditions. LOD and LOQ establish the lowest detectable and quantifiable levels. Linearity is evaluated from LOQ to 150% level to confirm proportional response. Accuracy is performed by spiking known SLS amounts onto stainless steel plates, followed by swabbing, extraction, and HPLC analysis. Range is established based on precision, accuracy, and linearity.
Solution stability checks mobile phase, standard solution, and sample solution stability under defined storage conditions. Robustness evaluates small changes in flow rate, column temperature, buffer ratio, and methanol ratio. Overall, the protocol ensures that the SLS HPLC method is specific, accurate, precise, linear, robust, stable, and suitable for intended cleaning validation use.