Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical Preparation
Table 3
Statistical data of the results of quantitative determination of hydrocortisone acetate and lidocaine hydrochloride in injection dosage form of investigated commercial product by NP-TLC with densitometry.
Parameter
Hydrocortisone acetate
Lidocaine hydrochloride
Number of analyses
6
6
The declared amount of respective substance in one ampoule [mg]
125
25
The average value of content [mg]
118.7
24.6
Minimum [mg]
115.9
23.7
Maximum [mg]
120.9
24.9
Variance ()
3.66
0.20
Standard deviation (SD)
1.9
0.4
Coefficient of variation (CV %)
1.60
1.79
Confidence interval of the mean value at significance level 95%
Content [%] of bioactive substance calculated in relation to the value declared by manufacturer