Abstract
A stability-indicating RP-HPLC method has been developed and validated for the simultaneous determination of methylparaben (MP), propylparaben (PP), diethylamino hydroxybenzoyl hexyl benzoate (DAHHB), and octinoxate (OCT) in topical pharmaceutical formulation. The desired chromatographic separation was achieved on the KinetexTM C18 (250 × 4.6 mm, 5 μm) column using gradient elution at 257 nm detection wavelength. The optimized mobile phase consisted of a buffer : acetonitrile : tetrahydrofuran (60 : 30 : 10, v/v/v) as solvent A and acetonitrile : tetrahydrofuran (70 : 30, v/v) as solvent B. The method showed linearity over the range of 0.19–148.4 μg/mL, 0.23–15.3 μg/mL, 1.97–600.5 μg/mL, and 1.85–451.5 μg/mL for MP, PP, DAHHB, and OCT, respectively. Recovery for all the components was found to be in the range of 98–102%. The stability-indicating capability of the developed method was established by analysing the forced degradation samples in which the spectral purity of MP, PP, DAHHB, and OCT, along with the separation of the degradation products from the analyte peaks, was achieved. The proposed method was successfully applied for the quantitative determination of MP, PP, DAHHB, and OCT in the lotion sample. The design expert with ANOVA software with the linear model was applied and a 24 full factorial design was employed to estimate the model coefficients and also to check the robustness of the method. Results of the two-level full factorial design, 24 with 20 runs including four centrepoint analysis based on the variance analysis (ANOVA), demonstrated that all four factors, as well as the interactions of resolution between DAHHB and OCT are statistically significant.
Highlights
IntroductionChemical sunscreens are generally aromatic compounds conjugated with an electron donating group and an electron acceptor group
Direct exposure to UV radiation causes pronounced harmful effects on human health such as sunburn, hyperplasia, and immuneosuppression, chronic responses including primarily photocarcinogenesis and photoaging [1].Chemical sunscreens are generally aromatic compounds conjugated with an electron donating group and an electron acceptor group
The primary target of developing the high-performance liquid chromatography (HPLC) method is to achieve the simultaneous determination of MP, PP, diethylamino hydroxybenzoyl hexyl benzoate (DAHHB), and OCT in topical formulations under common chromatographic conditions; those that are applicable to the routine quality control of products in the pharmaceutical and cosmetic industries
Summary
Chemical sunscreens are generally aromatic compounds conjugated with an electron donating group and an electron acceptor group. This chemical structure favours electron delocalization and helps the excitation of molecules from the ground state to an excited state. Chronic exposure to UVB (280–320 nm wavelengths) induces damage to human skin, such as burns and erythema. Volumes of evidence demonstrate that UVA radiation (320–400 nm) contributes to photoaging, which results in the accumulation of massive amounts of abnormal elastic material in the dermis of photoaged skin and modifications in the collagen structure [2,3,4,5,6]
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