A Novel Stability-Indicating HPLC Method with Kinetics Study for the Concurrent Analysis of Anti-Hypertensive Drug...

Stability-indicating methods are essential in pharmaceutical analysis to ensure the efficacy and safety of drugs throughout their shelf life. Atenolol and indapamide, both widely prescribed for hypertension, require robust analytical methods for the detection and quantification of their degradation products. Ensuring their stability is vital to maintaining therapeutic efficacy and safety, necessitating thorough analytical methods. A stability- indicating HPLC method facilitates the assessment of degradation products, contributing significantly to pharmaceutical quality control measures. HPLC is widely preferred due to its high precision, accuracy, and ability to separate complex mixtures effectively.

The objective of this study was to develop and validate a sensitive and robust stability- indicating HPLC method for simultaneously identifying atenolol and indapamide, even in the presence of their degradation products. The method proposed can enable comprehensive analysis under various stress conditions to monitor the stability and efficacy of the pharmaceutical compounds.

Chromatographic separation was achieved using a Shim-pack C18 column (250 × 4.6 mm i.d., 5 μm), with a mobile phase consisting of acetonitrile, methanol, and phosphate buffer (20:30:50 v/v/v) at pH 3.5. Detection was performed at 254 nm using a photodiode array (PDA) detector, with the column temperature maintained at 30°C. Atenolol and indapamide were subjected to stress testing under acidic, alkaline, oxidative, thermal, and photolytic conditions to evaluate degradation behavior. Specificity was confirmed through peak purity analysis.

The developed HPLC method provided excellent resolution, with retention times of atenolol and indapamide being 2.69 minutes and 10.07 minutes, respectively. Both drugs showed sensitivity to acidic, basic, and oxidative conditions, but they remained stable under thermal and photolytic stress. Degradation kinetics under acidic, alkaline, and oxidative conditions demonstrated the method's effectiveness in identifying degradation pathways and products. No interference from excipients or degradation products was observed, confirming the method's specificity. The technique achieved larger eco-analytical scale (78.5) and AGREE (0.59) scores compared to previously reported methods, indicating reduced environmental impact through eco-friendly solvents, minimized waste, and improved energy efficiency.

The developed stability-indicating HPLC method successfully identified and quantified atenolol and indapamide in the presence of degradation products. It offered high specificity, precision, and robustness, making it ideal for routine pharmaceutical analysis. The method distinguished between the active drugs and degradation products under various stress conditions, ensuring the long-term stability and efficacy of atenolol and indapamide formulations. These findings can significantly contribute to pharmaceutical quality control, ensuring drugs' safety and effectiveness.