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Shekhar M. Bhavsar et al

J. Chem. Pharm. Res., 2010, 2(2): 563-572

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specificity study are represented in Table 5. Typical overlay chromatograms of Diluent, Placebo, Standard, Placebo spiked with API and Test solution are shown in Fig.3.

Fig. 5: Overlay chromatogram of Diluent, Placebo, standard, placebo spiked with API and Test solution in specificity study

Robustness Robustness of the method was carried out by deliberately made small change in the flow rate, pH, organic phase ratio and column oven temperature. Results are presented in Table 6.

Compound

Normal Condition

% RSD (n=5) Changed Condition

Temperature Lornoxicam Thiocolchicoside

Normal 1.2 1.7

(-5°C) 0.9 0.8

(+5°C) 0.9 1.3

pH

Normal

(-0.2 unit)

(+0.2 unit)

Lornoxicam Thiocolchicoside Flow Rate Lornoxicam Thiocolchicoside

1.2 1.7 Normal 1.2 1.7

0.5 0.8 (-10%) 1.4 1.2

1.8 1.3 (+10%) 0.7 1.2

Mobile phase ratio

Normal

(-2%)

(+2%)

Lornoxicam Thiocolchicoside

1.2 1.7

1.7 1.1

0.3 1.4

Table 6: Results of Robustness study

Solution stability Solution stability period for standard and sample preparation was determined by keeping the solution for 24 hours at room temperature. After 4, 8, 12, 16, 20, 24 hours the solutions were analysed. Results related to solution stability are summarized in Table 7. No significant changes

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