Stability Indicating HPLC Method for the Simultaneous Quantification of Aspirin and Pravastatin in bulk and Tablets: Method Development and Validation

Abstract

The aim of the present study was to develop and validate a stability indicating HPLC method for the simultaneous determination of aspirin and pravastatin in bulk and pharmaceutical dosage forms. The chromatographic separation of aspirin, pravastatin and their degradation products was achieved on Phenomex C18 column with mixture of water, acetonitrile and acetic acid (40:59:01, v/v/v) as mobile phase in an isocratic elution mode at a flow rate of 1.5 mL/min. The method exhibited linearity in the concentration range of 20.5 -61.5 μg/mL and 10-30 μg/mL for aspirin and pravastatin, respectively. The limits of detection and quantification were 0.204μg/mL and 0.680 μg/mL for aspirin and 0.077 μg/mL and 0.256 μg/mL for pravastatin, respectively. The developed method was validated with respect to accuracy, precision, selectivity, specificity and robustness. All the parameters examined were within the acceptance limits. The stability-indicating power of the proposed method was proved by subjecting the drugs to hydrolytic (acid and base), oxidative, photolytic and dry heat stress conditions. The developed method was found to be suitable for routine analysis of aspirin and pravastatin simultaneous in the presence of its stress degradation products.

Pharmacodynamic and Pharmacokinetic Comparison between Selective and Non-selective COX-2 Inhibitors in Mice

“…The method of LLE was used, which was an accurate, simple, and approved procedure for nimesulide and aspirin, which are useful for precipitating proteins in the plasma (Ravi et al, 2017;Kim et al, 2022). The method is composed of the addition of acetonitrile to the plasma at 1:1 v/v.…”

Analytical Procedure for determination and statistical validation of novel drug Mafenide acetate in pharmaceutical formulations

“…Killing bacteria helps to promote wound healing and to decrease the risk of the bacteria spreading to surrounding skin or to the blood, thereby helping to prevent a serious blood infection (sepsis). [15][16][17][18] and the developed method was validated according to ICH guidelines for its various parameters [28][29] . In figure 2: RT was found to be good and the peak symmetry of drug was good.…”

“…From the above solution 1ml of solution is pipette out into a 10 ml volumetric flask and volume was made up to mark with water to give a solution containing 100 µg/ml of Mafenide acetate . Separately injected both the standard 15,16 (2 injections) and sample preparations (2 injections) into the chromatographic system and recorded the peak area responses.…”

“…The concept of analytical chemistry lies in the simple, precise and accurate measurements. These determinations require highly sophisticated instruments and methods like Mass Spectroscopy, Gas chromatography, HPTLC 14 , HPLC [15][16][17][18] , etc.…”

“…So it is a quantitative analytical method based on the structure and chemical properties of each active ingredient of the drug formulation. 3 Most of the drugs can be analyzed by HPLC [15][16][17][18] method because of several advantages like rapidity, specificity, accuracy, precision, reproducibility, ease of automation and eliminates tedious extraction and isolation procedures. On the literature survey, it was found that most of the analytical methods available for the above mentioned drug are applicable for quantification in plasma samples 22 , the most widely used method being liquid chromatography-mass chromatography 7 .…”