Data on validation using accuracy profile of HPLC-UV method

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.


Data
The choice of number of calibration standards and validation standards depends on the selected protocol. V2 was the type of the modified protocol.
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 À1 of AS, 0.325 mg ml À1 of PA, and 0.10 mg ml À1 of GU at optimal condition.

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 MWDÀ30,000 (RS) detector, a TCC-3Â00(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 À1 of 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
The use of validated methods is important for an analytical laboratory to show its qualification and competency Tables 1 and 2. The validation of quantitative analytical procedures is a great challenge for the quality control of industrial chemicals, specially concerning to the statistical parameters for accuracy criteria.
The present data shows relevant information that complement the related article and can be interesting for readers of the Data in Brief. The researchers can compare different regression models other than those used in the related article

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 À1 , respectively.
The separation was performed on A Phenomenex Luna ® CN column, (150 mm Â 4.6 mm, 5 mm), 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 mL.