Abstract
The data presented are related to the article entitled “Six Sigma quality approach for HPLC-UV method optimization” Ibrahim et al., 2019. The raw data of HPLC analysis of ascorbic acid (AS), paracetamol (PA) and guaifenesin (GU) are presented. Calibration standards were prepared at six concentrations levels (25%, 50%, 75%, 100%, 125% and 150%) each day and measured in triplicate. Validation standards were prepared at four concentration levels (25%, 60%, 100% and 150%) each day and measured in quintet. Three different series were used for method validation and prepared at the rate of one series per day.
Keywords: Accuracy profile, HPLC, Ascorbic acid, Paracetamol, Guaifenesin
Specifications table
| Subject area | Chemistry, Chromatography, Pharmaceutical science |
| More specific subject area | Validation |
| Type of data | Table and figure |
| How data was acquired | The analyses were performed using A Dionex UltiMate 3000 HPLC system equipped with a MWD−30,000 (RS) detector, a TCC-3×00(RS) column compartment oven, a LPG-3400SD Quaternary pump, and remote injector with Chromeleon®7 software. |
| Data format | Raw |
| Experimental factors | Ascorbic acid (AS), Paracetamol (PA) and Guaifenesin (GU). Stock solutions were prepared in methanol containing 2.5, 3.25, 1.0 mg ml−1of AS, PA and GU, respectively. Calibration standards were prepared by dilution of the stock standard solutions with buffer. The validation standards were prepared taking into considerations the effervescent granules matrix. |
| Experimental features | Three replicate for six concentration level were repeated for three days (calibration set). Five replicate for four concentration level were repeated for three days (validation set). |
| Data source location | Cairo, Egypt. |
| Data accessibility | The Data are available with this article |
| Related research article |
“Six Sigma quality approach for HPLC-UV method optimization” Ahmed M. Ibrahim, Hassan A.M. Hendawy, Wafaa S. Hassan, Abdalla Shalaby, Heba M. El-sayed. Microchemical Journal[1]. |
Value of the data
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1. Data
The choice of number of calibration standards and validation standards depends on the selected protocol. V2 was the type of the modified protocol.
Calibration standards were prepared at six concentrations levels (25%, 50%, 75%, 100%, 125% and 150%) each day and measured in triplicate.
Validation standards were prepared at four concentration levels (25%, 60%, 100% and 150%) each day and measured in quintet.
Three different series were used for method validation and prepared at the rate of one series per day.
Fig. 1 shows HPLC chromatogram of a validation standard solution containing 0.25 mg ml−1 of AS, 0.325 mg ml−1 of PA, and 0.10 mg ml−1 of GU at optimal condition.
Fig. 1.
HPLC chromatograms of a validation standard solution containing 0.25 mg ml−1 of AS, 0.325 mg ml−1 of PA, and 0.10 mg ml−1 of GU at optimal condition.
2. Experimental design, materials, and methods
AS, PA and GU were supplied by NODCAR. Methanol (HPLC grade), potassium dihydrogen phosphate, and ortho-phosphoric acid 85% were purchased from Merck. A validation matrix solution was prepared by dissolving sodium bicarbonate, citric acid anhydrous, tartaric acid anhydrous, povidone K25, aspartam, and disodium edetate in methanol in order to obtain 24.2, 9.6, 12.3, 1.2, 0.7 and 03 mg ml−1, respectively.
The separation was performed on A Phenomenex Luna® CN column, (150 mm × 4.6 mm, 5 μm), using an isocratic mode with a mixture of 50 mM potassium dihydrogen phosphate buffer adjusted with ortho-phosphoric acid to pH 2.2 as the aqueous component of the mobile phase and methanol in the ratio 85.9:14.1 (v/v) at 1 ml/min flow rate, with UV detector at 275 nm and a column temperature of 45 °C. The injected volume was 20 μL.
Acknowledgments
The authors thank the Micro-analysis Laboratory in NODCAR.
Footnotes
Transparency document associated with this article can be found in the online version at https://doi.org/10.1016/j.dib.2019.103877.
Transparency document
The following is the transparency document related to this article:
References
- 1.Ibrahim A.M., Hendawy H.A.M., Hassan W.S., Shalaby A., El-sayed H.M. Six Sigma quality approach for HPLC-UV method optimization. Microchem. J. 2019;144:303–308. [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.