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-March, 2009
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RESEARCH ARTICLE
ABSTRACT
Two simple, accurate, precise, reproducible, requiring no prior separation and economical procedures for simultaneous
estimation of Losartan Potassium and Amlodipine Besylate in tablet dosage form have been developed. First method
employs formation and solving of simultaneous equation using 208 nm and 237.5 nm as two analytical wavelengths
for both drugs in methanol. The second method is Q value analysis based on measurement of absorptivity at 242.5 nm
(as an iso-absorptive point) and 237.5 nm. Losartan Potassium and Amlodipine Besylate at their respective max 208
nm and 237.5 nm and at isoabsorptive point 242.5 nm shows linearity in a concentration range of 2-20 g/mL.
Recovery studies range from 99.95% for Losartan Potassium and 99.33% for Amlodipine Besylate in case of
simultaneous equation method and 102.93% for Losartan Potassium and 101.02% for Amlodipine Besylate in case of
Q - analysis method confirming the accuracy of the proposed method. The proposed method is recommended for
routine analysis since it is rapid, simple, accurate and also sensitive and specific by no heating and no organic solvent
extraction.
KEY WORDS: Losartn Potassium, Amlodipine Besylate, max , Simultaneous equation method, Q analysis
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Asian J. Research Chem. 2(1): Jan.-March, 2009
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Table 1: Linear regression analysis of calibration curves with their respective absorptivity values.
Parameter Method I Method II
LP AB LP AB
Beer’s law limit ( g ml-1) 2-20 2-20 2-20 2-20
Correlation coefficient (r) 0.9988 0.9991 0.9993 0.9970
Molar absorptivity (lit/mole/cm) 42942.37 19435.23 21396.44 18694.30
Sandell's sensitivity 0.0107 0.0210 0.021546 0.021872
(mcg/Sq.cm/0.001)
Slope 0.0955 0.0468 0.04602 0.04325
Intercept -0.0063 -0.0158 -0.017533 -0.02353
Method Drug Label Claim % Label Claim ± R. S. D. Coefficient of variance % Recovery* (Mean ±
R. S. D)
LP 5 103.39 ± 1.224 0.0155 99.95± 0.97
I AB 50 105.06± 3.25 0.111 99.33± 0.72
LP 5 103.93± 2.66 0.072 102.93± 0.21
II AB 50 105.05± 3.25 0.111 101.02± 0.37
Average of three determinations; R.S.D.; Relative Standard Deviation
Table 4: Results of intermediate precisions.
Method I Method II
Day % Label claim estimated % Label claim estimated
(Mean ± % R.S.D.) (Mean ± % R.S.D.)
LP AB LP AB
Intraday 105.83 100.04 100.87 112.5
± 0.73 ± 0.43 ± 0.56 ± 2.2
Interday 106.86 108.05 99.25 100.6
± 1.27 ± 1.71 ± 1.76 ± 0.36
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was filtered through whatman filter paper no. 41 and then Accuracy:
final volume of the solution was made up to 50 ml with To ascertain the accuracy of the proposed methods,
methanol to get a stock solution containing 100 g ml-1of LP recovery studies were carried out by standard addition
and 100 g ml-1 AB. Appropriate aliquots of LP and AB method at three different levels (80%, 100% and 120%).
within the Beer’s law limit were taken. In Method I, the Percent recovery for LP and AB, by both the methods,
concentration of both LP and AB were determined by was found in the range of 101.44% to 100.17%.
measuring the absorbance of the sample at 208 nm and 237.5
nm. Values were substituted in the respective formula to Linearity:
obtain concentrations. The linearity of measurement was evaluated by
analyzing different concentration of the standard
For Method II, the concentration of both LP and AB solution of LP and AB. For simultaneous equation
were determined by measuring absorbance of the sample method and Q analysis, the Beer- Lambert’s
at 242.5 nm and 237.5 nm and values were substituted in concentration range was found to be 2-20 g/ml for LP
the respective formula to obtain concentrations. Results and AB.
of tablet analysis are shown in Table 3.
Precision:
VALIDATION: Precision was studied to find out intra and inter-day
The method was validated according to ICH Q2B variations in the test method of LP and AB. Calibration
guidelines for validation of analytical procedures in order to curves prepared in medium were run in triplicate in same day
determine the linearity, sensitivity, precision and accuracy and for three days. %RSD (relative standard deviation) were
for the analyte.
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Asian J. Research Chem. 2(1): Jan.-March, 2009
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calculated which should be less than 2 %. The results are respectively. We are also thankful to Mr. Shreeniwas
tabulated in Table 4. Mohite sir for his moral support and guidance.
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