Academic Journal
Hampi Tariki Kit: thin-layer chromatography for semiquantitative screening of solid oral medicines in Peru.
| Τίτλος: | Hampi Tariki Kit: thin-layer chromatography for semiquantitative screening of solid oral medicines in Peru. |
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| Συγγραφείς: | Mónico-Rosales GM; Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Peru., Mostacero-Rodríguez FR; Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Peru., Quispe-Paitán BR; Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Peru., Rodríguez-Calzado EJ; Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Peru., Ortiz-Bernaola JJ; Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Peru., Nuñez-Galindo A; Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Peru. |
| Πηγή: | Revista peruana de medicina experimental y salud publica [Rev Peru Med Exp Salud Publica] 2026 Aug 28; Vol. 43 (3), pp. 311-320. Date of Electronic Publication: 2026 Aug 28. |
| Τύπος έκδοσης: | Journal Article; Validation Study |
| Γλώσσα: | English; Spanish; Castilian |
| Στοιχεία περιοδικού: | Publisher: Instituto Nacional de Salud Country of Publication: Peru NLM ID: 101227566 Publication Model: Electronic Cited Medium: Internet ISSN: 1726-4642 (Electronic) Linking ISSN: 17264634 NLM ISO Abbreviation: Rev Peru Med Exp Salud Publica Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Lima : Instituto Nacional de Salud |
| Ιατρικοί όροι (MeSH): | Bulk Drugs*/analysis, Chromatography, Thin Layer/methods ; Administration, Oral ; Peru ; Tablets |
| Περίληψη: | 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. |
| Competing Interests: | The authors declare that the rapid testing methods for drug quality verification are in the patent registration process before the Instituto Nacional de Defensa de la Competencia y de la Protección de la Propiedad Intelectual (INDECOPI), and that the associated portable case has legal protection as a utility model. This situation constitutes a potential technological conflict of interest; however, the authors declare that it did not influence the study design, experimental execution, analysis, or interpretation of the results. Its possible impact on technology transfer, access and reproducibility, and use by third parties should be considered in future implementation stages. |
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| Grant Information: | EI-037-15 Peru INS Instituto Nacional de Salud |
| Contributed Indexing: | Keywords: Counterfeit Drugs; Health Surveillance; Pharmaceutical Technology; Quality Control; Thin-Layer Chromatography Local Abstract: [Publisher, Spanish; Castilian] Desarrollar y validar métodos rápidos por cromatografía en capa fina (CCF) integrados en el kit Hampi Tariki para el tamizaje semicuantitativo de ingredientes farmacéuticos activos (IFAs) en medicamentos sólidos orales comercializados en el Perú. [Publisher, Spanish; Castilian] Se desarrollaron y validaron ocho métodos por CCF para tabletas y cápsulas con aciclovir, dicloxacilina, dimenhidrinato, ibuprofeno, diclofenaco sódico, paracetamol, norfloxacino, fenazopiridina clorhidrato, clorfenamina maleato y fenilefrina clorhidrato. Se evaluaron 57 muestras comerciales disponibles en el mercado nacional, procedentes de diferentes laboratorios fabricantes, incluyendo productos de marca y genéricos previamente verificados como conformes por métodos oficiales en el Centro Nacional de Control de Calidad (CNCC) del Instituto Nacional de Salud (INS). Se utilizaron placas de gel de sílice 60 F254, estándares de referencia y disolventes de grado analítico. La validación se realizó según la guía ICH Q2(R1), evaluando selectividad, linealidad, precisión, exactitud, límite de detección visual y robustez. [Publisher, Spanish; Castilian] Los métodos permitieron diferenciar visual y densitométricamente niveles equivalentes al 80%, 100% y 120% del contenido declarado. Los valores del factor de retención (Rf ) se ubicaron entre 0,20 y 0,85, y las formulaciones multicomponente presentaron resolución cromatográfica ≥1,0. Los coeficientes de correlación fueron superiores a 0,99 para la linealidad del sistema y del método; la repetibilidad presentó coeficientes de variación menores a 3,0%, la precisión intermedia menores a 5,0%, y el sesgo frente a cromatografía líquida de alta eficiencia (HPLC) se mantuvo dentro del intervalo de ±3,00%. Las variaciones deliberadas evaluadas en robustez no produjeron cambios significativos en los valores de Rf. [Publisher, Spanish; Castilian] Los métodos desarrollados demostraron desempeño analítico adecuado como pruebas rápidas de tamizaje semicuantitativo. Integrados en el kit Hampi Tariki, constituyen una propuesta con potencial para apoyar la identificación preliminar de muestras sospechosas y priorizar su confirmación mediante HPLC u otros métodos oficiales. |
| Substance Nomenclature: | 0 (Bulk Drugs) 0 (Tablets) |
| Entry Date(s): | Date Created: 20261013 Date Completed: 20261013 Latest Revision: 20261014 |
| Update Code: | 20261015 |
| DOI: | 10.17843/rpmesp.2026.433.15446 |
| PMID: | 42867952 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1726-4642 |
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| DOI: | 10.17843/rpmesp.2026.433.15446 |