Asian Journal of Pharmaceutical Analysis

R. Revathi ¹, V. S. Saravanan ¹, T. Ethiraj ², Jhansi Lakshmi Marreddy ¹

Affiliations
1 Department of Pharmaceutical Analysis, The Erode College of Pharmacy and Research, Erode, Tamil Nadu, IN
2 Department of Pharmaceutics, The Erode College of Pharmacy and Research, Erode, Tamil Nadu, IN

Abstract

A simple reverse phase liquid chromatographic method was developed and validated as per the ICH guidelines for the quantitative determination of candesartan cilexetil in pharmaceutical dosage forms. The mobile phase consisted of 0.02 M mono basic potassium phosphate buffer: acetonitrile: triethyl amine (40:60:0.2) and adjust pH to 6.0 with ortho phosphoric acid. The eluent was monitored at 254 nm, at a flow rate of 2 mL/min and retention time was observed at 9.153 min. The linearity was observed from 0.08071-0.24213 mg/mL with R2= 0.998. The LOD and LOQ were found to be 0.00005 mg/mL and 0.00017 mg/mL respectively. This method was also validated and can be successfully applied for routine analysis.

Keywords

Candesartan Cilexetil, RP-HPLC, Validation.

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R. Revathi ¹, P. Venkata Naga Suresh ¹, M. Koteswara Rao ¹, T. Ethiraj ², S. Rajarajan ³

Affiliations
1 Dept. of Pharmaceutical Analysis, The Erode College of Pharmacy and Research, Erode-638112, Tamil Nadu, IN
2 Dept. of Pharmaceutics, The Erode College of Pharmacy and Research, Erode-638112, Tamil Nadu, IN
3 Dept. of Pharmacy Practice, The Erode College of Pharmacy and Research, Erode-638112, Tamil Nadu, IN

Abstract

Objective of the present work is to optimize condition to develop UV zero order, first derivative spectrophotometric method and a simple, rapid and reproducible RP-HPLC method for the estimation of didanosine in selected dosage form. Chromatographic separation of didanosine was achieved with chromosil column (150 mm x 4.6 mm i.d, 5μ particle size), mobile phase used was phosphate buffer: acetonitrile: methanol in the ratio of 20:35:45 with 0.6 ml/min flow rate. The chromatograms were recorded at 248nm.The retention time was < 3 minutes (2.72±0.1). The method was validated for system suitability, precision, accuracy, linearity and robustness. The isocratic LC method offers simplicity, selectivity, precision, accuracy and less time consuming. Hence these two methods can be used for the routine analysis of the estimation of didanosine in Pharmaceutical dosage form.

Keywords

Didanosine, Accuracy, Linearity, Retention Time.

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