Quality By Design (QbD) Based Approach to Analytical RP-HPLC Method Development and Validation of Combined Etophylline & Theophylline in Bulk and Tablets.
Main Article Content
Abstract
Introduction: A convenient, accurate, rapid, precise, and sensitive RP-HPLC method involving UV detection was developed and validated for the determination and quantification of Etophylline and Theophylline in tablet dosage form.
Objective: To develop and validate a simple, precise and reliable, economical method using RP-HPLC as per ICH guidelines.
Method: The determination was carried out on a Kromasil C18 (250 x 4.6 mm, 5 μm) column using a filtered and degassed mixture of methanol: Buffer pH 4.5 (94: 06 v/v) as mobile phase at a flow rate of 1 ml/min and effluent was monitored at 272 nm.
Results: The retention time found for Etophylline was 1.535 min and for Theophylline 2.477 min. Etophylline and Theophylline showed a linear response in the concentration range of 10-60μg/ml and 20-120μg/ml individually. The correlation coefficient for Etophylline and Theophylline was 0.9993 and 0.9998, respectively.
Conclusion: The method was validated in terms of linearity, precision, accuracy, specificity, robustness, and system suitability. The proposed method can be useful in the quality control of bulk manufacturing and pharmaceutical dosage forms.