Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF NAPHAZOLINE NITRATE AND HYDROCORTISONE IN NASAL DROP

Maurya Udayshankar J.*, Dr. Vinay C. Darji, Prajapati Ketulkumar, Ashwinkumar Panchal, Jaymin G. Patel and Bhumi R. Patel

ABSTRACT

A Simple, rapid, Precise and accurate Reverse Phase High Performance Liquid Chromatography (RP-HPLC) Method for Simultaneous Estimation of Naphazoline Nitrate and Hydrocortisone in Nasal Drop. The RP-HPLC method was developed for the Simultaneous Estimation of Naphazoline Nitrate and Hydrocortisone in their Combined dosage form development method has been achieved. The Seperation was attained by Column C18 (25 Cm x 0.46 Cm) Hypersil BDS and Buffer pH (3.5):Methanol (50:50 v/v ) (Flow rate-1.0 ml/min) as mobile phase at a Flow rate 1ml per minute Detention was carried out of Wavelength of 238 nm retention time of Naphazoline Nitrate and Hydrocortisone were found to be 5.623 and 3.293 min respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for range of for Naphazoline Nitrate 6.25-18.75μg/mL and 5-15 μg/mL for Hydrocortisone. The Percentage recovery obtained for Naphazoline Nitrate and Hydrocortisone were found to be in range 99.613-99.850, 99.781-100.067 respectively. Development method was found to be accurate, Precise and rapid for Simultaneous estimation of Naphazoline Nitrate and Hydrocortisone in their combined dosage form.

Keywords: Naphazoline Nitrate, Hydrocortisone, Stability Indicating RP-HPLC METHOD, VALIDATION.