Abstract
The objective of this study was to develop a rapid and sensitive UV spectroscopic and RP-HPLC method for the analysis of Amlodipine Besylate and Indapamide in bulk drug and pharmaceutical dosage form by using the most commonly employed C-18 column with UV-detection. Acetonitrile: acetate buffer pH-5 (40: 60 % v/v) with 1.2 mL / min flow rate was selected as mobile phase.In the HPLC method, the conditions were optimized to obtain an adequate separation of components. Initially, various mobile phase compositions were tried to separate active ingredients. This method has been found to be better than previously reported methods, due to its wider range of linearity, use of readily available mobile phase, lack of extraction procedures. Hence thesemethodscould be used in quality control for routine analysis of finished products of amlodipine besylate and Indapamide simultaneously without any interference.
Highlights
Analytical method development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals
In order to select suitable solvent for determination of Indapamide, various solvents were selected for the solubility studies [4,5] and it was found that Indapamide was freely soluble in the methanol, ethanol, and slightly soluble in water
The system suitability parameters were evaluated from standard chromatograms by calculating the % RSD from six replicate injections for Amlodipine Besylate and Indapamide retention times and peak areas
Summary
Analytical method development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. Pharmaceutical products formulated with more than one drug, typically referred to as combination products, are intended to meet previously unmet patients need by combining the therapeutic effects of two or more drugs in one product. These combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods. The official test methods that result from these processes are being used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products. A proper analytical procedure for the drug may not be available in the literature due to patent Regulations
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