A new and simple quantitative analysis method for the determination of Guaifenesin (G) and Ephedrine HCl (E) binary mixtures was developed and validated. Phosphate buffer-methanol combination (60:40, v=v) was chosen as an isocratic mobile phase and adjusted to pH 3 for this liquid chromatographic method which was developed for the simultaneous analysis of G and E combination. The method was observed in concentration ranges of 30-100 lg mL À1 (G) and 15-50 lg mL À1 (E). The total run time for detections performed at 212 nm was less than 10 min.The reverse phase-high performance liquid chromotography (RP-HPLC) method developed in this study was successfully applied to pharmaceutical preparations in syrup dosage form and human plasma samples (in vitro) without liquid-liquid extraction. And the statistical comparison of this method was performed both in pharmaceutical preparations and human plasma samples.
In this study, an Inverse Phase‐High Performance Liquid Chromatography method was developed for the determination of the quantities of Etodolac and Thiocolchicoside active ingredients contained in the same tablet form (Etotio tablet). For this purpose; Etodolac and Thiocolchicoside in the pharmaceutical combination were determined simultaneously using Inverse Phase‐High Performance Liquid Chromatography method. This developed high‐performance liquid chromatography method was also used for the simultaneous in vitro quantity determination of Etodolac and Thiocolchicoside in human plasma. Plasma samples were analyzed with the Inverse Phase‐High Performance Liquid Chromatography method without any need for extraction process and very high recoveries were obtained with this chromatographic method. Method validity was tested by applying all the validation parameters for the data obtained from both studies (in solvent and plasma media). Results obtained in plasma media and solvent media were compared statistically with Anova test and it was found that there is no significant difference (at 95% possibility level) between the two methods from average and standard deviation aspects.
A new, simple and rapid reverse phase-high performance liquid chromatography-diode array detection (RP-HPLC-DAD) method has been developed using sibutramin (S) as internal standard for quantitative determination of guaifenesin (G) and validated both in syrup dosage forms and spiked human plasma samples. The analysis was carried out within 10 min on Inertsil C18 column using isocratic mobile phase consists of phosphate buffer and methanol with pH 3 (60:40, v/v) at a flow-rate of 1 mL min -1 and detection at 212 nm. The concentration-response relationship was linear over a concentration range of 10-100 µg mL -1 for guaifenesin. The developed liquid chromatographic method was successfully applied for the routine analysis of guaifenesin in a cough syrup and human plasma samples without liquid-liquid extraction for quality control purposes. After the method development, bioanalytical method validation was applied. For this purpose, all the validation parameters such as intra-day and inter-day precisions, accuracy, specificity, selectivity and recovery were determined. After the validation procedure, the results were evaluated statistically.
Paracetamol (acetaminophen) is a painkiller and antipyretic agent. Acetylcysteine is a mucolytic agents and it is N-acetylated derivative of L-Cysteine, which is a natural amino acid. Guaifenesin (glyceryl guaiacolate) is an expectorant agent. All these three agents are active ingredients of several cold and pain killer medicines sold in Turkish market today (Parol, Asist Plus, Cinetix, Mucoplus and Vicks Vapo Expectorant). A spectroscopic quantitative determination method not requiring a derivation process has been developed successfully for all these agents and their amounts in these trade preparations were determined. Finally, bioanalytical method validation was performed for the developed method and main validation parameters were determined.
DOI: http://doi.org/10.1002/sscp.201900036
The cover picture shows an easy, fast, economical, repeatable, sensitive and new Reverse Phase‐High Performance Liquid Chromatography method been developed for the simultaneous quantitative estimation of Etodolac and Thiocolchicoside combination in human plasma (in‐vitro). Three‐dimensional spectrum of Thiocolchicoside and Etodolac in plasma. Determination of Etodolac and Thiocolchicoside without any need for extraction process in human plasma was carried out at 259 nm by using Photo Diode Array Detector as seen from the three‐dimensional spectrum of Thiocolchicoside and Etodolac in plasma. Very high recovery values as 97.50–100.24% for Etodolac and 97.21–100.68% for Thiocolchicoside were obtained. Furthermore, an environmental friendly and more economical method was developed by decreasing the methanol rate within the mobile phase mixture. This method was also applied in human plasma media and it was seen that it can be easily and successfully applied in routine quantity analysis processes.
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