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36 February / March 2020 2.7.7. Stability


The stability of mobile phase, standard and sample solutions were carried out by keeping the solutions for 28 days for mobile phase and 2 days for standard and sample solutions, and observing for changes in the area and the retention of the peaks. In addition, the standard and test solutions kept refrigerated and at room temperature (RT) were also monitored at the determined periods and the % change calculated and compared a chromatogram of freshly prepared solutions. Relative difference (%) of SX and FP was calculated based on the values of initial conditions and it should be smaller than 2.0%. The results show that the standard solution was stable for 30 hours at 25 °C, stable for 7 days at RT and 14 days when refrigerated. The test solution was found to be stable for 30 hours at 25°C for the assay, and mobile phase was stable for 28 days in ambient conditions.


3. Discussion & Conclusion


Replacing Sodium Dodecyl Sulphate with Potassium Dihydrogen Phosphate


makes this method safer in terms of working conditions. In addition, employing UV detection provides simplicity when considering sample preparation compared to FLR detection which is more sensitive to any kind of contamination. Moreover, using the wavelength gradient, produced a maximum response at the wavelength maximum for SX and FP.


To conclude, the validation studies done in accordance with ICH guidelines prove that the suggested method is accurate, precise, robust, specific and selective.


References


1. Anwar, M., El-Haggar, R, Zaghary, W (2015), Profiles of Drug Substaces, Excipients and Related Methodology Chapter Five- Salmeterol Xinofoate, DOI: https://doi. org/10.1016/bs.podrm.2015.02.002


2. Kercsmar, C. (2012) Wheezing in Older Children:Asthma, Kendig& Chernick’s Disorders of the Respiratory Tract in Children 8th Edition, DOI: https://doi.org/10.1016/ C2011-0-05011-1


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3. McKeage, K., Keam SJ.(2009), Salmeterol/ Fluticasone Propionate: A Review of Asthma, Drugs Volume 69, Issue 13, DOI: https://doi. org/10.2165/11202210-000000000-00000


4. USP 41 NF 36 Fluticasone Propionate and Salmeterol Inhalation Powder


5. British Pharmacopoeia (2016), Draft Monograph of fluticasone and salmeterol inhalation powder pre-dispensed vol. 3.


6. Sodium Dodecyl Sulfate SDS , http://www. merckmillipore.com/TR/tr/product/msds/ MDA_CHEM-817034?Origin=SERP


7. Potassium Dihydrogen Phosphate PDP; http://www.merckmillipore.com/ TR/tr/product/msds/MDA_CHEM- 104873?Origin=PDP


8. EMEA, (2005), International Conference on Harmonization (ICH) Q2 (R1): Validation of Analytical Procedures—Test and Methodology


9. Kazakevich Y.V, LoBrutto R. (2007), HPLC for Pharmaceutical Scientists, Wiley


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