Volume 9 ; Issue 2 ; in Month : July-Dec (2026) Article No : 183
Nagavalli D, Nishvanth F, Kumudhapriya MS

Abstract

Objective: To develop and validate a simple, precise, and accurate reversed-phase High-performance liquid chromatographic (RP-HPLC) method for the estimation of salicylic acid in bulk drug and cosmetic face serum formulations, in accordance with ICH Q2(R1) guidelines. Methods: Chromatographic separation was achieved on a C18 column using a mobile phase of methanol and potassium dihydrogen phosphate buffer (pH 3.5) in the ratio 60:40 (v/v) containing 0.1% orthophosphoric acid, delivered under isocratic elution with UV detection at 296 nm. The method was validated for linearity, precision, accuracy, ruggedness and robustness as per ICH Q2(R1) guidelines. Results: Salicylic acid eluted at a retention time of 3.683 minutes, with theoretical plates greater than 2000 and a tailing factor below 2.0, indicating good system suitability. The method exhibited excellent linearity over the concentration range of 10–60 µg/mL (r² = 0.9997), with a limit of detection (LOD) and limit of quantification (LOQ) of 0.00000335 µg/ mL and 0.00001017 µg/mL, respectively. Precision studies yielded %RSD values below 2%, and accuracy, assessed by the standard addition method at 50%, 100%, and 150% of label claim, showed recovery values ranging from 98.7% to 101.2%. All ruggedness and robustness parameters complied with ICH Q2(R1) acceptance criteria. Conclusion: The developed RP-HPLC method is simple, rapid, cost-effective, and environmentally friendly, and is suitable for the routine quality control and quantitative determination of salicylic acid in bulk drug substances and cosmetic formulations.

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