Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR AZELASTINE HYDROCHLORIDE IN AZELASTINE HYDROCHLORIDE NASAL SPRAY BY RP-HPLC METHOD

Jay Prakash Gupta*, Shabnam Khan, Ramakant Sharma, Jeevan Patel, Rakesh Kumar Jatav and Rakesh Patel

ABSTRACT

A simple, specific, accurate and precise RP-HPLC method has been developed for the Azelastine Hydrochloride in Azelastine Hydrochloride Nasal Spray. Linearity curve was linear with correlation coefficient of more than 0.999 for Azelastine Hydrochloride. The percentage recovery of the drug was found to be in the range of 99.0-101% indicating accuracy and reliability of method. The method was found to be precise as indicated by the repeatability of the analytical procedure, showing % RSD < 2%, that is 1.0%. RP-HPLC method was developed using Kinetex C18, 250 x 4.6 mm, 5µm, 100Å. The samples were analysed using mobile phase A: 50% buffer, 40% of methanol and 10% of acetonitrile and mobile phase B: 10% buffer, 20% of methanol and 70% of acetonitrile as the mobile phase at the flow rate of 1.2 ml/min in gradient mode and detection wavelength is 239 nm, azelastine eluted about 6.4 minutes and gave sharp peaks with high theoretical plate count and low tailing factor. The proposed method was validated as per ICH guidelines. Hence, the developed analytical method can be utilized for the routine analysis of Azelastine Hydrochloride in Azelastine Hydrochloride Nasal Spray dosage form.

Keywords: Azelastine Hydrochloride, Azelastine Hydrochloride Nasal Spray, UV detector, RP-HPLC method, Antihistaminic drug.