Wednesday , 20 September 2017

Development of New Validated Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Rosuvastatin and Aspirin in Bulk and Pharmaceutical Dosage Form

G. Gurum Jyothi, Ramesh Dhani*, V. Hari Baskar, M. Pavani
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Muthukur, SPSR Nellore– 524 346

Simple precise and accurate method was developed for the estimation of Rosuvastatin and Aspirin. The mobile phase consisting of 0.01N Phosphate buffer 32 as mobile phase A and acetonitrile 68 as mobile phase B gave retention time for Rosuvastatin and Aspirin was found to be 2.2min and 4.0min. The column was used: ODS (150 mm 4.6 mm, 5mm) with flow rate 1ml/min using PDA detection at 290nm. The linearity regression data showed a good linear relationship over a concentration range of 25-150 µg/ml. The estimation of formulation was recorded, peak area was noted and the amount was determined using calibration curve. The correlation coefficient was found to be 0.999 respectively. The accuracy limit is the percentage recovery should be in the range of 97.0% – 103.0%. The total recovery was found to be 100.34% and 100.22% for Aspirin and Rosuvastatin. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility. The acceptance criteria for LOD and LOQ are 3 and 10.The LOD and LOQ for Aspirin was found to be 3.00 and 9.98 and LOD and LOQ for Rosuvastatin was found to be 3.02 and 10.00. The precision was within the acceptance criteria less than 2.0%. Estimation of Rosuvastatin and Aspirin was achieved by using WATERS HPLC 2965 SYSTEM. The normal spectrum of Rosuvastatin and Aspirin was recorded in water. Based on the absorbance scale λmax was found to be 290nm.
Keywords: Rosuvastatin, Aspirin, RP-HPLC

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