Tue, 19 Dec 2017

Method Development and Validation for Simultaneous Estimation of Levosalbutamol Sulphate and Budesonide in Bulk and Pharmaceutical Dosage Form by RP-HPLC

 

Subhash Dadhich*1, Sanjay Sharma1, Anil Bhandari1, Ankit Agarwal2, Sunil Kumar Tiwari2, Kashyap Nagariya2

1.Faculty of Pharmaceutical Sciences, Jodhpur National University, Jodhpur, Rajasthan, India – 342003

2.R & D Division, Ahlcon Parenterals (I) Limited, Bhiwadi, Rajasthan, India – 301019


 

ABSTRACT

A simple, precise, accurate and stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method is developed for estimation of Levosalbutamol sulphate and Budesonide in bulk and suspension for inhalation dosage form. The method employed, with reverse phase Inertsil® 5μ C18 (250 × 4.0 mm) column in an isocratic mode, with mobile phase of acetonitrile: buffer in the ratio 40:60 (%v/v). The flow rate was 0.8 ml/min and effluent was monitored at 266 nm. Retention time was found to be 3.16 min., 17.94 min. and 20.90 min. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 25 – 150% of the working concentration (r2 > 0.999) respectively. The LOD and LOQ values for were found to be 0.43, 0.72, 0.97 and 1.24 µg/ml respectively. No chromatographic interference from placebo and degradants were found. The proposed method was successfully used for estimation of Levosalbutamol sulphate and Budesonide in bulk and suspension for inhalation dosage forms.

Keywords: Levosalbutamol sulphate, Budesonide, RP-HPLC, Validation, Stability-indicating method.


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