Research Article
Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical Preparation
Table 2
Validation of the method. Data for the quantitative determination of hydrocortisone acetate and lidocaine hydrochloride by NP-TLC with densitometrya.
| | Method characteristic | Results
Hydrocortisone acetate | Results
Lidocaine hydrochloride |
| | Specificity | Specific | Specific | | Range g·spot−1 | | | | Linearity g·spot−1 | = 8721.6 (±245.4) + 1990.6 (±30.0) ·
= 7; = 0.9994; = 221.7; = 4391.5; < 0.0001 | = 1722.4 (±52.9) + 3075.5 (±30.4) ·
= 6; = 0.9998; = 36.7; = 10223; < 0.0001 | | Accuracy | | | | for 50% standard solutions added () | = 97.6% CV = 2.60% | = 97.6% CV = 2.12% | | for 100% standard solutions added () | = 99.0% CV = 1.62% | = 97.0% CV = 1.44% | | for 150% standard solutions added () | = 98.0% CV = 2.53% | = 99.3% CV = 1.85% | | Detection limit (LOD)
g·spot−1 | 0.066 | 0.090 | | Quantification limit (LOQ)
g·spot−1 | 0.198 | 0.270 | | Precision (CV % ) | | | | for 10.0 hydrocortisone acetate and 2.0 lidocaine hydrochloride g·spot−1 () | 0.93% | 1.01% | | for 7.5 hydrocortisone acetate and lidocaine hydrochloride 1.5 g·spot−1 () | 0.92% | 1.69% | | for 5.0 hydrocortisone acetate and 1.0 lidocaine hydrochloride g·spot−1 () | 1.32% | 0.97% | | Robustness (CV %) | Robust | Robust |
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: peak area AU; : amount of analyzed drug g·spot−1; : correlation coefficient; : recovery %; CV: coefficient of variation %.
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