VALIDATION OF HPLC METHOD FOR TIMOLOL MALEATE DETERMINATION IN NANO-POLYMERIC FORMULA
Abstract
In this study, a sensitive, selective, and precise HPLC method for the detection of timolol maleate (TM), one of the anti-haemangioma ß-blockers, in nano-polymeric formulation was developed. Chromatographic separation was achieved using a mobile phase of 10 mM ammonium acetate buffer pH=3.5: acetonitrile (80:20, v/v) in isocratic mode of elution at a flow rate of 1.0 ml/min on Luna Phenomenex C18 ODS column (150mm x 4.6mm, 5μm). Validation has been performed on the method's system suitability, selectivity, linearity, accuracy, precision, and robustness. The results showed that the precision and uniformity values of the nanoparticle samples were within an acceptable range for both between and within days. The retention time of timolol maleate was observed to be around 6.8 minutes in the absence of any peak intervention. The standard curve exhibited a strong linear relationship, and the recovery values satisfied the specified range criteria consistently over a period of three consecutive days. After different ways of making sample preparations, which should affect the amount of contained drug, the employed technique successfully determined the percentage of drugs encapsulation in a nanopolymer formulation with dependable outcomes. The penetration profile of the nanoparticle formula and free drugs on mouse skin membranes was successfully determined utilizing the same approach that had previously undergone an extra verification step. The improved and validated method has proven its reliability and suitability in measuring the amount of timolol maleate in nano-polymer products to evaluate the efficiency of encapsulation and its penetration profile, which is a crucial factor in building drug delivery systems utilizing nanotechnology.
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