Development and Validation of an Alternate Stability-indicating UV Spectrophotometric Analytical Method for Aspirin in Tablets

Abstract

Aspirin is a drug that has been used for widely for more than a century. Numerous stability-indicating analytical methods have been reported over the years. A new stability indicating method was developed for the accurate quantitation of aspirin in tablets using the partial least squares calibration algorithm. This method is specific for the determination of aspirin and its main degradation product; salicylic acid in tablets using ultraviolet spectrophotometry. The calibration matrix needs only 13 binary solutions and the method showed good linearity from 30 to 70 µg/ml for aspirin and 0 to 40 µg/ml for salicylic acid. Moreover, a full validation according to the International Council of Harmonization guidelines was carried out covering precision, recovery, sensitivity, sample stability and tolerance. The method was applied to developed and commercial aspirin tablets. The proposed method represents a reliable choice to be used as a routine method for quality control of newly manufactured products.

Stability evaluation of Acetylsalicylic acid in commercial Aspirin tablets available in the Iraqi market ‎

“…HPLC [17], spectrometry [10], and acid-base titration [13] are frequent efficient techniques used in drug analysis and stability monitoring during shelf life. For aspirin steadiness monitoring in dosage form, UVspectrophotometer has been located to be gone well with for the intent as it is notable to precisely measure over a giant concentration vary with immoderate accuracy and precision [18]. However, with the introduction of poly component methods, UV spectrophotometry validated a great prevalent standard performance in the quantitation of compounds in combos barring the previous separation.…”

“…However, with the introduction of poly component methods, UV spectrophotometry validated a great prevalent standard performance in the quantitation of compounds in combos barring the previous separation. This trouble posted the best gain over HPLC methods, such as limit cost, an awful lot of a lot of lots much less time of assessment, and minimal organic solvent lost [18,19]. Moreover, these techniques were statistically compared to chromatographic data suggesting possible interchangeability between UV spectrophotometric techniques and HPLC for ongoing stability study of finished pharmaceutical products [20,21].…”

Development and validation of liquid chromatography method for determination of acetylsalicylic and salicylic acid in dosage forms

“…Pored različitih modifikacija metode tečne hromatografije, korišćene su hromatografija na tankom sloju (14), GC/MS-MS (eng. gas chromatography tandem-mass spectrometry, (15)) UVspektrofotometrija (16), derivativna spektrofotometrija (17) i elektrohemijske metode (18)(19)(20).…”

Detección espectrofotométrica y cuantificación de ácido acetil salicílico en fármacos

“…El AAS/aspirina actualmente es muy utilizado en todo el mundo, esto se debe a sus propiedades farmacológicas, por ende el estudio de este fármaco será permanente y constante (Dolores, Morales, Garduño, Villaseñor, & López, 2016). Una vez administrado el AAS, llega al torrente sanguíneo, se hidroliza a AS (Ácido Salicílico), el cual cumple el rol del principio activo y da lugar a la acción terapéutica del fármaco en el organismo (Cofan & Radovan, 2011;Neuberger, Jooß, Flottmann, Scriba, & Neusüß, 2017).…”