Abstract

RP – HPLC METHOD DEVELOPMENT, METHOD VALIDATION AND SIMULTANEOUS ESTIMATION OF CLINIDIPINE AND OLMESARTAN MEDOXOMIL IN SOLID DOSAGE FORM

B. Sneha Reddy*, Dr. K. Swathi Priya, Mrs. P. R. Sudha Rani, Dr. D. Nivedita, Mr. Ch. Bharath

Abstract

Validation is an essential process in the field of analytical chemistry, crucial for verifying that analytical methods are appropriate for their intended applications. This step ensures that the resulting data are trustworthy, consistent, and reproducible. The validation process assesses different parameters, each aimed at evaluating a specific dimension of the method’s performance, including selectivity, precision, accuracy, linearity, range, stability, and the limits of detection and quantification. The peaks for Clinidipine and Olmesartan Medoxomil were well-separated, occurring at retention times of 6.381 and 5.070 minutes, respectively, with a flow rate of 1 ml/min in isocratic mode over a total run time of 15 minutes. The analysis utilized a Welchrom column measuring 250 mm x 4.6 mm with a particle size of 5 μm, employing a mobile phase consisting of ammonium acetate buffer, water, and methanol in a ratio of 20:10:70, with detection at 265 nm. The assay percentages were 99.50% for Clinidipine and 99.01% for Olmesartan Medoxomil. Linearity was established within the range of 40-120 ppm for Clinidipine and 32-96 ppm for Olmesartan Medoxomil, demonstrating correlation coefficients of 0.9947 and 0.9961, respectively. The newly proposed method was validated against ICH guidelines and was determined to be specific, sensitive, precise, reliable, and linear. This method is likely to effectively quantify Clinidipine and Olmesartan Medoxomil in commercially available formulations.

Keywords: Clinidipine, Olmesartan Medoxomil, Method development and validation, ICH guidelines, and RP-HPLC.