You are hereMETHOD DEVELOPMENT AND VALIDATION OF QUETIAPINE FUMARATE BY RP - HPLC METHOD

METHOD DEVELOPMENT AND VALIDATION OF QUETIAPINE FUMARATE BY RP - HPLC METHOD


s.no

   PARAMETERS

           LIMIT

OBSERVATION

REMARKS

1

System suitability

Theoretical Plates should not less than 2500 Tailing factor should not more than 2.0

Theoretical Plates 2902

Tailing factor 1.5

Good peak within limit

2

Precision

A)System precision

B)Method precision


RSD NMT 2.0%

RSD NMT 2.0%


0.14

0.13

Good within range


3

Linearity

Correlation coefficient NLT 0.99

1.000

 Obtained linear line

4

Accuracy

% Recovery range 98% – 102%

99.3%

Recovery with in range

5

Robustness

system suitability parameters should comply

complies

Complies

6

LOD

S:N Ratio should be about 3

2.92

With in range

7

LOQ

S:N Ratio should be about 10

10.03

With in range

DISCUSSION
A RP-HPLC method with UV detection for the assay of Quetiapine fumarate was developed and validated. The results showed that the method is very selective, no significant interfering peak was detected; accurate, with the percentage recoveries > 99; and reproducible, with the %RSD < 1%. The method was sensitive; a little as 0.072μg/ml could be detected with the LOQ of 0.24μg/ml. The method involves use of a simple methanol with the HPLC water and minimum sample preparation, encouraging its application in quality control for analysis of Quetiapine fumarate in bulk samples, raw materials and final dosage forms.

Acknowledgements
Authro are grateful to GNV Chandra Shekar, Pharma Train, Kukatpally, Hyderabad for authentication of drug and methodology.

REFERENCES
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