International Journal of Pharmaceutical Chemistry and Analysis


Stability-indicating RP-HPLC Method for Estimation of Salmeterol xinafoate in Bulk and in Pharmaceutical Formulation


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Author Details: P. S. Jain*, A. P. Gorle, S. S. Patil, R. S. Chavan, P. R. Bari, S. J. Surana

Volume : 2

Issue : 1

Online ISSN : 2394-2797

Print ISSN : 2394-2789

Article First Page : 28

Article End Page : 33


Abstract

 A new simple, precise, accurate and selective RP-HPLC method has been developed and validated for estimation of salmeterol xinafoate in pharmaceutical formulation. The method was carried out on a Qualisil RP C-18 (250 mm x 4.6 mm, 5 μm) column with a mobile phase consisting of buffer: acetonitrile: methanol (45:25:30 v/v/v), pH adjusted to 6 with diammonium hydrogen orthophosphate and flow rate of 0.5 mL/min. Detection was carried out at 250 nm. The retention time for salmeterol xinafoate was found to be 7.41 min. The salmeterol xinafoate followed linearity in the concentration range of 1- 6 μg/mL (r2= 0.9984). The amount of the drug estimated by proposed method was found to be in good agreement with label claim. The developed method was validated for sensitivity, accuracy, precision, ruggedness and robustness. The LOD and LOQ were found to be 0.10 and 0.29 μg. Salmeterol xinafoate was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and thermal conditions. This indicates that the drug is susceptible to acid, base, oxidation and thermal conditions. The degraded product was well resolved from the pure drug with significantly different Retention Time. The proposed method can be used for routine analysis of salmeterol xinafoate in bulk drug and pharmaceutical formulation.

 

Keywords: Salmeterol xinafoate, RP-HPLC Validation, methanol, Stability; Degradation.