Hampi Tariki Kit: thin-layer chromatography for semiquantitative screening of solid oral medicines in Peru.

Abstract

Objectives: To develop and validate rapid thin-layer chromatography (TLC) methods integrated into the Hampi Tariki kit for the semiquantitative screening of active pharmaceutical ingredients (APIs) in oral solid medications marketed in Peru.

Materials and methods: Eight TLC methods were developed and validated for tablets and capsules containing acyclovir, dicloxacillin, dimenhydrinate, ibuprofen, diclofenac sodium, paracetamol, norfloxacin, phenazopyridine hydrochloride, chlorphenamine maleate, and phenylephrine hydrochloride. Fifty-seven commercial samples available in the national market, from different manufacturing laboratories, including branded and generic products previously verified as compliant by official methods at the Centro Nacional de Control de Calidad (CNCC) of the Instituto Nacional de Salud (INS), were evaluated. Silica gel 60 F254 plates, reference standards, and analytical grade solvents were used. Validation was performed according to ICH Q2(R1) guideline, evaluating selectivity, linearity, precision, accuracy, visual detection limit, and robustness.

Results: The methods allowed for visual and densitometric differentiation of levels equivalent to 80%, 100%, and 120% of the declared content. Retention factor (Rf ) values were between 0.20 and 0.85, and multicomponent formulations presented chromatographic resolution ≥1.0. Correlation coefficients were greater than 0.99 for system and method linearity; repeatability showed coefficients of variation less than 3.0%, intermediate precision less than 5.0%, and bias against high-performance liquid chromatography (HPLC) remained within the ±3.00% range. Deliberate variations evaluated in robustness did not produce significant changes in Rf values.

Conclusions: The developed methods demonstrated adequate analytical performance as rapid semiquantitative screening tests. Integrated into the Hampi Tariki kit, they constitute a proposal with potential to support the preliminary identification of suspicious samples and prioritize their confirmation by HPLC or other official methods.