Method development and validation for the simultaneous estimation of Nebivolol hydrochloride and S (-) Amlodipine besilate in tablet dosage form by RP – HPLC

About author
Prabhakaran. V.*, Sekar. S., Baskar.E., Raghuprasath. V.R.
Formulation Research and Development Department,
The Madras Pharmaceuticals, Karapakkam, Chennai, Tamil Nadu, India.
Email: [email protected]

ABSTRACT
High Performance Liquid Chromatography method was developed and validated in a simple, specific and precise manner for Nebivolol HCl and Amlodipine besilate in a combined solid dosage form. Nebivolol hydrochloride, a long acting, cardioselective β – blocker and Amlodipine besilate, a calcium channel blocker was considered in combination for the treatment of hypertension. The HPLC (WATERS ALLIANCE 2695) – Separation module with photo diode array detector (WATERS 2996) with CN (Zorbax) column (250 x 4.6 mm), 5 µ (Agilent) was used. The retention times of Nebivolol HCl and Amlodipine besilate was found to be 13.568 min and 9.554 min respectively. The developed method was validated as per ICH Guidelines for specificity, linearity, accuracy, precision, range, detection limit, quantitation limit, ruggedness and robustness. The applicability of the developed method for the quantification of Nebivolol HCl and Amlodipine besilate present from marketed tablet formulation was evaluated. The results confirmed the suitability of developed method for routine analysis of Nebivolol HCl and Amlodipine besilate in combined dosage forms.
Key words: HPLC, hypertension, retention time, validation