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16 May / June 2017


Table 2. Regression Statistics. Comp.


Conc. mg.mL-


¹ Multiple R


Salmeterol Xinafoate and its impurities SX


Impurity D Impurity G


Regression equation


0.00036-0.006 0.9994 y = 11049424.10x - 892.09


0.00015-0.006 0.9998 y = 18451400.15x - 845.06


0.00019-0.006 0.9997 y = 10908751.42x - 394.94


Fluticasone Propionate and its impurities FP


0.00019-0.06 Impurity A Impurity B Impurity C Impurity D Impurity E Impurity F Impurity G Impurity H Impurity I


0.9996 y = 18161540.20x + 2781.22


0.000175-0.06 0.9993 y = 15947485.28x + 6212.84


0.000215-0.06 0.9997 y = 15035392.88x - 821.75


0.000155-0.06 0.9996 y = 16799866.62x + 3399.86


0.0001-0.06 0.00025-0.06 0.00018-0.12 0.00011-0.06 0.00011-0.06


0.9997 y = 16780655.36x + 4420.93


0.9995 y = 18172893.75x + 2637.08


0.9996 y = 19029385.27x + 8642.36


0.9992 y = 15743836.63x + 5587.32


0.9993 y = 18890732.96x + 3287.02


0.000095-0.06 0.9996 y = 19410148.10x + 9259.12


t-Stat p-Value Lower Upper 95% confi dence interval 133.73 211.93 174.80 1.34E-17 1.34E-19 9.23E-19 10865326.49 18257413.08 10769697.31 11233521.71 18645387.23 11047805.52


189.44 145.16 211.02 187.62 217.77 161.25 199.10 133.06 138.96 100.30


2.87E-25 1.19E-23 6.35E-26 3.29E-25 4.09E-26 2.74E-24 1.43E-25 4.03E-23 2.2E-23 2.1E-21


17955921.36 15711857.00 14882571.47 16607820.41 16615385.15 17931180.98 18824395.52 15490053.94 18599164.41 18995104.20


18367159.05 16183113.57 15188214.28 16991912.82 16945925.58 18414606.52 19234375.02 15997619.32 19182301.51 19825193.79


Figure 3. HPLC Chromatogram Which Shows the Quanification of all 16 Known Related Substances of SX and FP


50/500 mcg (Salmeterol/Fluticasone Propionate) Inhalation Powder was weighed into a 10 mL volumetric fl ask, 5 mL acetonitrile was added and placed in and ultrasonic bath for 10 minutes to ensure dissolution. The resultant solution is diluted to volume with diluent A and ultrasonicated for a further 5 minutes. (CSalmeterol CFP


: 5 mg/mL). 2.7. Spiked Test Solution : 0.5 mg/mL,


500 mg sample from Cyplos Sanohaler 50/500 mcg (Salmeterol / Fluticasone Propionate) Inhalation Powder (equivalent to 5 mg SX and 50 mg FP) was weighed into 10 mL volumetric fl ask. Then 0.1875 mL from each salmeterol related impurities (A, B, C, D, E, F and G) and 0.25 mL from each fl uticasone propionate related impurities (A, B, C, D, E, F, G, H and I) were pipetted


out onto powder and made up to volume with diluent B. (CSalmeterol


: 0.0015 mg/mL, CFP mg/mL) 2.8. System Suitability


To ensure that the chromatographic system was in a suitable state, six replicate injections were made of SX and FP, ensuring that the relative standard deviations (RSD) for the


: 0.02


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