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Dushyant Patel Extractive Spectrophotometric Method

S.K.P.C.P.E.R., Kherva 74 M .Pharm. Thesis

d) Intermediate precision (Reproducibility):

¾ The intraday and interday precision of the proposed methods were performed by

analyzing the corresponding responses 3 times on the same day and on 3 different days

over a period of 1 week for 6 different concentrations of standard solutions of GBP (20,

40, 60, 80, 100 and 120 µg/ml) for BCG and GBP (40, 50, 60, 70, 80 and 90 µg/ml) for

BTB. The results were reported in terms of %relative standard deviation (%RSD).

e) Limit of detection and Limit of quantification:

¾ The limit of detection (LOD) and limit of quantification (LOQ) of the drug were derived

by calculating the signal-to-noise (i.e. 3.3 for LOD and 10 for LOQ) ratio using the

following equations designated by International Conference on Harmonization (ICH)

guideline:

LOD = 3.3 Χ σ/S and LOQ = 10 Χ σ/S

Where, σ = the standard deviation of the response, S = slope of the calibration curve

5.3 RESULTS AND DISCUSSION:

METHOD VALIDATION:

5.3.1 Linearity:

¾ Linear correlation was obtained between absorbance versus concentrations of GBP in the

ranges of 10-120 µg/ml

for BCG and 40-90 µg/ml

for BTB. The linearity of the

calibration curve was validated by the high values of correlation coefficient of regression

line (Table No. 5.1; Figure 5.5 and 5.6).

y=0.0065x+0.08 95

R²=0.9966

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0 20406080100120140

Conce ntra ti on(µg/ml)

Absorb ance

Figure 5.5 Calibration curve for GBP-BCG

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