Mon, 18 Dec 2017

A Development and Validation of RP-HPLC Method For Simultaneous Estimation of Nadifloxacin and Clobetasol Propionate In Its Pharmaceutical Dosage Form

Nidhi Patel*1, Pooja Patel1, Dhananjay Meshram1

1. Department of Quality assurance, Pioneer Pharmacy Degree College, Vadodara-390019, Gujarat, India.


ABSTRACT

A novel, simple, precise, rapid, reproducible and cost effective RP-HPLC method was developed and validated for the simultaneous estimation of Nadifloxacin and Clobetasol propionate in its pharmaceutical dosage form. The chromatographic separation was carried out using C18 Shim pack XR ODS II (250 mm × 4.6 mm, 5µm) column with mobile phase comprising of Acetonitrile : Water (50:50)(%v/v). Flow rate was maintained 1.0 mL/min and quantitation was carried out using UV detection at 242nm. Retention time of Nadifloxacin and Clobetasol propionate were found to be 2.64 min and 6.19 min respectively. The method was validated by assessing different parameters such as specificity, linearity, precision, accuracy, robustness, LOD and LOQ for the developed method. The linearity range 20-240 µg/mL and 1-12 µg/mL were selected for Nadifloxacin and Clobetasol propionate respectively. The correlation coefficient (r2) for Nadifloxacin and Clobetasol propionate were found to be 0.9995 and 0.9999 respectively. The limit of detection for Nadifloxacin and Clobetasol propionate were found to be 0.029 µg/mL and 0.21 µg/mL. The limit of quantitation for Nadifloxacin and Clobetasol propionate were found to be 0.089 µg/mL and 0.64 µg/ml respectively. Percentage recovery was found to be 99% to 100.56% for Nadifloxacin and 99.37% to 99.79% for Clobetasol propionate. All the validation parameters were with-in the acceptance limit. The relative standard deviation (%RSD) was found to beless than 2% in all the assessed parameters. The developed HPLC method can successfully used for the quantitative estimation of both the drugs in its formulation.

Keywords: Nadifloxacin, Clobetasol propionate, RP-HPLC, Simultaneous determination, Validation 


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