Document Type: Research Paper
Department of Pharmacy, Tripura University (A Central University), Suryamaninagar, Agartala, Tripura, 799022
Inspecting Officer (Drugs), O/o. The Deputy Drugs Controller, Pandit Nehru Complex, Gourkhabasti, Agartala, Tripura, 799006.
Department of Pharmaceutical Analysis and Quality Assurance, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P
Dean & HOD, Department of Pharmacy, Tripura University, (A Central University), Suryamaninagar, Agartala-799022
Background: The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC method in which the peaks will be appear with short period of time as per ICH Guidelines.
Materials and Methods: The separation was achieved on a a stainless steel analytical column, Eclipse XDB plus C18 column (4.6 X 150 mm; 5 μm) in an isocratic mode. The mobile phase was composed acetonitrile and 0.01 M ammonium acetate (pH adjusted to 4.5 using glacial acetic acid), which were mixed in the ratio of 50 : 50. The flow rate was monitored at 1.0 mL/min. The wavelength selected for detection was 265 nm.
Results: The retention time found for amlodipine besylate and nebivolol hydrochloride was 2.967 and 3.510 min respectively. The % recovery was 100.20- 100.86 for amlodipine and 100.20 - 100.78 for nebivolol. The linearity was established in the range of 5-25 µg/mL for amlodipine and 10-50 µg/mL for nebivolol. The slope, intercept, and correlation coefficient were found to be 314.2x, +162.4, and 0.999 for amlodipine besylate and 248x, -305.7, and 0.9998 for nebivolol hydrochloride, respectively. The limits of detection for amlodipine besylate and nebivolol hydrochloride obtained by the proposed method was 0.07 and 0.20 µg/ml and limits of quantification for amlodipine besylate and nebivolol hydrochloride obtained by the proposed method was 0.23 and 0.61 μg/mL respectively.
Conclusion: The method was found to be suitable for the quality control test of amlodipine besylate and nebivolol hydrochloride simultaneously in a bulk drugs as well as in a formulations.