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Development of The Stable, Reliable, Fast and Simple RP-HPLC Analytical Method for Quantifying Diphenhydramine-Hcl (DPH) In Pharmaceuticals
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| Author:
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H.N.K.AL-SALMAN, ERFAN A.S.ALASSADI, RAJAA HUSSEIN FAYADH, HUSSEIN H.HUSSEIN, EKHLAS QANBER JASIM
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| Abstract:
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Context: In this manuscript, a high-performance liquid chromatography (HPLC) technique for the estimation of Diphenhydramine HCl (DPH)in pharmaceuticals was described and developed. Methods: The reversed-phase HPLC (RP-HPLC) process was urbanized and the results obtained to determine the form of Diphenhydramine. Chromatographic analysis was performed in HPLC-ultraviolet (HPLC-UV) system with Ion Pac column; Arcus EP-C18; 5 µm, 4.6 mm× 250 mm, with Methanol: acetonitrile: water: 10mM Heptan sulfonate and 13 mM Triethylamine, (10:26:64) at pH 3.3 as mobile phase, at a flow rate of 1.0 ml/min. UV detection in the HPLC system was performed at 254 nm.Results: The strategy was approved for exactness, accuracy, particularity, linearity, and affectability. The maintenance time for the Diphenhydramine was 9.9 min. Alignment plots were straight over the focus ranges 1–5 µg/L for the Diphenhydramine HCl (DPH). The limit of detection was 1.04473µg/ml and the limit of quantitation was 3.16585µg/ml. The exactness of the proposed strategy was controlled by recuperation studies and discovered to be from 96.0% to 100%. Conclusion:The modern HPLC-UV method was used in the analysis of samples of commercial medicine and under a registered trademark in the Iraqi Ministry of Health, and the reliability of the proposed method for analysis was verified. All research results indicate that accuracy, precision, and quality are within acceptable limits, and the results additionally demonstrated that there is no critical contrast between the qualities acquired from the proposed strategy.
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| Keyword:
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Diphenhydramine-HCl (DPH), Stress Degradation, DPH Crud
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.04.608
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| Download:
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