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development and validation of a reversed phase hplc method ... - ijrpc

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IJRPC 2012, 2(4) Laskhmana Rao et al ISSN: 22312781<br />

Table 2: Accuracy data for proposed <strong>method</strong> a<br />

Amount <strong>of</strong> drug added %Mean recovery (n=6) %RSD<br />

Spiked level <strong>of</strong> (µg/b<strong>and</strong>)<br />

drug (%) LEVO MONT LEVO MONT LEVO MONT<br />

80 40 80 99.9 100.57 0.15 0.52<br />

100 50 100 98.38 99.84 0.196 0.25<br />

120 60 120 101.9 100.92 0.18 0.36<br />

a n = 6<br />

Drug<br />

LEVO<br />

MONT<br />

a n = 6<br />

Table 3: Precesion data <strong>of</strong> proposed <strong>method</strong> a<br />

Concentration Intra-day precision Inter-day precesion<br />

(µg/mL) Mean peak area %RSD Mean peak area %RSD<br />

25 972357 1.21 985674 1.32<br />

50 1976121 1.26 1995609 01.21<br />

75 2903486 1.41 2938957 0.5<br />

50 2367187 1.6 2406781 1.4<br />

100 4673428 0.52 4657587 0.29<br />

150 6643621 0.52 6594732 0.46<br />

Table 4: Robustness for flow rate variation <strong>of</strong> LEVO <strong>and</strong> MONT<br />

Parameter Flow rate variation- Flow rate variationminus<br />

(0.8 mL/min) plus (1.2 mL/min)<br />

LEVO MONT LEVO MONT<br />

% RSD for five<br />

replication<br />

0.2 0.4 0.3 0.6<br />

Retention time 4.57 7.83 1.86 4.77<br />

Theoretical Plates 5325 12674 8674 8731<br />

Tailing Factor 1.02 1.34 1.05 1.23<br />

Table 5: Analysis <strong>of</strong> marketed formulations by proposed <strong>method</strong><br />

Br<strong>and</strong> name Label claim (mg) Amount Found (mg)* % Label claim<br />

Montair LC LEVO 5 4.96 99.2<br />

MONT 10 10.24 102.4<br />

Leveta M LEVO 5 5.06 101.2<br />

MONT 10 9.98 99.8<br />

*(n=6)<br />

Fig. 1: Molecular structure <strong>of</strong> levocetirizine<br />

1060

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