Research Article

Validation of an RPHPTLC-Densitometric Method Using Silica Gel 60 RP18WF254 for Simultaneous Determination of Nicotinamide in Selected Pharmaceutical Formulations

Table 1

Statistical analysis of nicotinamide content in its commercial drugs using the proposed RPHPTLC-densitometric method.

ParameterPharmaceutical products
Nicotinamide tablets
(Vitamin PP)
(Product 1)
Nicotinamide tablets
(Vitamin PP)
(Product 2)
Nicotinamide injection solution
(Vitamin PP)
(Product 3)

Number of determinations ()666
Label claimed of nicotinamide (mg)200200100
Mean amount of nicotinamide (mg)198.4198.699.4
Minimum amount of nicotinamide (mg)195.9195.897.5
Maximum amount of nicotinamide (mg)202.2201.2101.2
Variation ()4.803.101.53
Standard deviation (SD)2.21.81.2
Coefficient of variation (CV, %)1.110.911.21
The 95% confidence interval of arithmetic mean = 198.4 ± 2.2 = 198.6 ± 1.8 = 99.4 ± 1.2
Percentage amount of nicotinamide found (%) in relation to declared value 99.2%99.3%99.4%