ABSTRACT
Two simple, fast, environmental friendly and reliable spectrophotometric methods were developed for determination of tapentadol hydrochloride in bulk and synthetic mixture containing the possible excipients. The first method is based on measuring the first derivative values of aqueous solution of the drug at 228 nm (method I) and the second method based on measuring the second derivative values at 235 nm (method II). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of tapentadol 5- 60 μg.ml-1 for both methods. The proposed methods have been extensively validated as per ICH guidelines. The developed spectrophotometric methods in this study are simple, accurate, precise, specific and reproducible and can be directly applied to pharmaceutical dosage form.
ABSTRACT
Objective: The macroporous adsorptive resin chromatographic column combining with polyamide chromatographic column was used to separate the flavonoides, phenylethanoidglycosides, iridoid glycosides, and high polarity ingredients (such as alkaloid salts and sugars) in industrialization. Methods: Water extract from Lamiophlomis rotata (WELR) was separated and enriched by series and parallel method of polyamide and macroporous adsorptive resins and CCPP serial laminar analysis, and was ultrafiltrated by LM-125 ultrafiltration apparatus, then was dried under the reduced pressure by JYT-50 LN multipurpose kinesis back flow extract concentration subassembly. WELR, 70% ethanol solution eluate I (70% ethanol solution eluted polyamide column), 70% ethanol solution eluate II (70% ethanol solution eluting macroporous resin column), and ultrafiltration matter. The total flavonoids and total phenylethanoid glycosides were determined by aluminum nitrate-sodium nitrite UV spectrophotometry. The total iridoid glycosides were determined by the first derivative spectrophotometry. Shanzhiside methylester and 8-O-acetyl shanzhiside methylester were determined and the changes of total iridoid glycosides ingredients were investigated in the different elution requirement by HPLC. Results: Ethanol (70%) was used as dissolvent. Using the "introduction from superior surface" sample introduction mode and "introduction from superior surface" eluting mode in polyamide chromatographic column, the "introduction from inferior surface" sample introduction mode and "introduction from superior surface" eluting mode in the macroporous adsorptive resin chromatographic column, yields of 70% ethanol solution eluate I, 70% ethanol solution eluate II, and ultrafiltration matter were 2.43%, 20.80%, and 82.60%, respectively. Conclusion: This production technology may transform the experimental achievement to industrial production successfully.
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OBJECTIVE:To determine vitamin E in muyan capsule.METHODS:The content of vitamin E in muyan capsule was determined by first-derivative spectrophotometry with detection wavelength at 230nm.RESULTS:The linear range of vitamin E was 14.98 ～ 24.96? g? mL-1(r=0.999 8).The average recovery of vitamin E was 100.1%(RSD=0.26%).CONCLUSION:The method is simple,rapid and accurate,and applicable for the determination of vitamin in muyan capsule.
ABSTRACT
OBJECTIVE:To establish a good method for determining the dissolution rates of diclofenac sodium suppository METHODS:The dissolution method Ⅰ and Ⅱ of ChP(2000) were compared,the first derivative spectrophotometry was used and the parameters(T50,Td,m) obtained from these samples were brought for correlation analysis RESULTS:The dissolution rate of diclofenac sodium suppository from the dissolution method Ⅰ and Ⅱ were remarkably different,and the dissolution method Ⅱ was better than Ⅰ CONCLUSION:The method established by this study is suitable for the quality control of diclofenac sodium suppository,and the percentage of dissolution of diclofenac sodium suppository in 45min more than 80% is the standard of quality control