Mon, 20 Nov 2017

Method Development and Validation of Levosalbutamol by RP-HPLC In Bulk And Nebulizer Dosage Form

DineshKumarAgrawal*1, C. S. Sharma1, C. P. Saluja2

1.Bhupal Nobles’ College of Pharmacy Udaipur , Rajasthan, India -313002

2. 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 Ipratropium Bromide in bulk and nebulizer 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 77:23 (%v/v). The flow rate was 1.3 ml/min and effluent was monitored at 210 nm. Retention time was found to be 3.05 min., and 10.59 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 be0.72,0.43, 1.24and 0.97 and μg/ml respectively. No chromatographic interference from placebo and degradants were found. The proposed method was successfully used for estimation of Levosalbutamol sulphate and Ipratropium bromide in bulk and nebulizer dosage forms.

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


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