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Determination of salmeterol xinafoate and its degradation products according to ICH guidelines with use of UPLC technique

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985 ISSN 0326-2383

KEY WORDS:Degradation, Salmeterol xinafoate, Stability indicating assay, Stress testing, UPLC, Validation.

* Author to whom correspondence should be addressed. E-mail: piyush.trivedi@rgtu.net, prof_piyushtrivedi@yahoo.com

Latin American Journal of Pharmacy

(formerly

Acta Farmacéutica Bonaerense)

Lat. Am. J. Pharm.

30

(5): 985-990 (2011)

Regular Article Received: February 11, 2010 Revised version: February 14, 2010 Accepted: February 4, 2010

Determination of Salmeterol Xinafoate and its Degradation Products

According to ICH Guidelines with use of UPLC Technique

Pratibha PATEL, Kapendra SAHU, Chandrabose KARTHIKEYAN,

N.S. HARI NARAYANA MOORTHY, & Piyush TRIVEDI*

School of Pharmaceutical Sciences, Rajiv Gandhi Proudyogiki Vishwavidhyalaya,

Air Port by pass road, Gandhi nagar, Bhopal-462036, India

SUMMARY. The objective of reducing analysis time and maintaining good efficiency, there has been sub-stantial focus on high-speed chromatographic separations. Recently, commercially available ultra perfor-mance liquid chromatography (UPLC) has proven to be one of the most promising developments in the area of fast chromatographic separations. In this work, a new isocratic reverse phase chromatographic stability indicating assay method was developed using UPLC for salmeterol xinafoate bulk drug. A novel stability-indicating UPLC assay method was developed and validated for salmeterol xinafoate and its degradation products. An isocratic UPLC method was developed to separate the drug from the degrada-tion products, using an Acquity UPLC BEH C18 (50 mm x 2.1 mm column). Mixture of methanol: 0.06 % and pH 3.4 ammonium acetate (65:35) was used as mobile phase. The flow rate was kept 0.6 mL/min and the detection was carried out at 228 nm. The linearity of the proposed method was investigated in the range of 10-50 μg/mL (r2= 0.999) for salmeterol xinafoate. The method detection limit was 0.5 μg/mL and

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