You are hereANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF SALMETEROL BY UV SPECTROSCOPY

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF SALMETEROL BY UV SPECTROSCOPY


2.5 Wavelength scanning and determination of absorption maximum
From the stock solution of salmeterol, known concentration of 10μg/ml is prepared by suitable dilution with ethanol. Wavelength scanned for the maximum absorption of drug solution using UV-Visible spectrophotometer within the wavelength region of 200–400 nm against blank ethanol. The wavelength that shows the peak with a highest absorbance is considered as absorbance maximum of the drug. The result is presented in table 1.

2.6 Linearity studies for Candesartan analytical method
Stock solution was subsequently diluted with ethanol to get 2μg/ml, 4μg/ml, 6μg/ml, 80μg/ml, 10μg/ml, 12μg/ml 14μg/ml, 16μg/ml, 18μg/ml 20μg/ml. The results are tabulated and the linearity curve was constructed by plotting concentration vs. absorbance value. The result is presented in table 1 and fig. 3.


Fig 2 depicting linearity for concentration range.


FIG. 3: Standard curve of salmeterol

Regression equation; y = 0.026x + 0.01
R2 = 0.999

X – Axis: Concentration

Y- Axis: Absorbance

2.7 Precision
The precision of method was ascertained; the percent relative standard deviation were calculated and presented.

2.7.1 Inter day and intraday studies for Candesartan analytical method
The prepared stock solution was subsequently diluted to get 10 μg/ml. The resulting solution absorbance was measured at detection wavelength of 252.4 nm using double beam UV spectrophotometer against blank of ethanol. The findings was made at different time intervals in day times in a day and performed continuously for six days. The results obtained were tabulated and studied for inter day and intraday variation. The results are tabulated in table 1.

2.8 Accuracy studies: The accuracy/recovery studies were carried out with the commercial preparation of salmeterol and percentage recoveries was calculated. The reproducibility of estimation was determined by performing the drug content of different samples. The results of accuracy studies were expressed in %. The result is presented in table 1.

2.9 Assay studies: The assay studies were carried out with the help of candesartan SMEDDS. The percentage purity was calculated. Convert the normal mode obtained spectra to first order derivative. The reproducibility of estimation was determined by performing the drug content of different samples. The results of assay studies were expressed in %. The result is presented in table 1.

S.NO.

 PARAMETERS

OBTAINED RESULT

1

Detection Wavelength

252.4 nm

2

Linearity and Range

6 - 14 µg/ml

3

Sensitivity

0.18 µg/cm2/ 0.001 AU

4

Limit Of Detection

4.699 µg/ml

      5

Limit Of Quantification

14.24 µg/ml

6

Intraday precision

% RSD less than 2%.

7

Inter day precision

% RSD less than 2%.

8

Accuracy studies

Within the limit 95 -105%

9

Assay

Within the limit 95 -105%

Table 1 depicting the validation parameters

3. Results and Discussion
Literature review revealed that area under curve and first order derivative spectroscopy method is available for estimation of Salmeterol but the specific absorptivity and calibration curve method are not available so these methods are selected for the analytical method development of Salmeterol in bulk and pharmaceutical dosage forms. The developed method is validated for repeatability, reproducible and the accuracy and precision. In the inter day and intraday study of standard graph, the % RSD is less than 2% indicating the developed method is reproducible. The different levels of standard concentration solutions are measured forabsorbance value and actual concentration is calculated. The results showed that the amount recovered is 100% indicating the first order derivative spectroscopic method is accurate and precise.

4. Conclusion
Proposed study describes new UV spectrophotometric (Calibration curve, Specific absorptivity) method for the estimation of Salmeterol in all its formulation. The method was validated and found to be simple, sensitive, and accurate and precise. Percentage of recovery shows that the method is free from interference of the excipients used in the formulation. Therefore the proposed method can be used for routine analysis of estimation of Salmeterol in all its pharmaceutical dosage form.

5. Acknowledgements
I sincerely thank my Principal and management staff & lab technicians for their contribution in carrying forward the research work. I would also sincerely thank specially to my teacher, Mr. Yogesh Vaishnav, who has been my role model as well as my inspiration, for his active and Kind guidance and for providing the necessary support and basic facilities in lab.

NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.

SUBMIT YOUR ARTICLE/PROJECT AT articles@pharmatutor.org

Subscribe to PharmaTutor Alerts by Email

FIND OUT MORE ARTICLES AT OUR DATABASE


FIND MORE ARTICLES

Subscribe to RSS headline updates from:
Powered by FeedBurner