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Development and Validation of RP-HPLC Method for Content Analysis of Didanosine in Dosage Form


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

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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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  • Development and Validation of RP-HPLC Method for Content Analysis of Didanosine in Dosage Form

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Authors

R. Revathi
Dept. of Pharmaceutical Analysis, The Erode College of Pharmacy and Research, Erode-638112, Tamil Nadu, India
P. Venkata Naga Suresh
Dept. of Pharmaceutical Analysis, The Erode College of Pharmacy and Research, Erode-638112, Tamil Nadu, India
M. Koteswara Rao
Dept. of Pharmaceutical Analysis, The Erode College of Pharmacy and Research, Erode-638112, Tamil Nadu, India
T. Ethiraj
Dept. of Pharmaceutics, The Erode College of Pharmacy and Research, Erode-638112, Tamil Nadu, India
S. Rajarajan
Dept. of Pharmacy Practice, The Erode College of Pharmacy and Research, Erode-638112, Tamil Nadu, India

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.