Sensitive Spectrophotometric Determination of Atorvastatin in Pharmaceutical Formulation by Ion Pair Complexation with Pararosaniline Hydrochloride

Abstract

Objectives: A sensitive visible spectrophotometric method was developed for the determination of atorvastatin in tablet dosage form. Methods: Atorvastatin (ASN) has a free carboxylic moiety in its structure, which when being deprotonated in basic buffered medium facilitates its ion pairing with the cationic pararosaniline dye. Results: The red colored ion pair is easily extractable in organic solvent and exhibits maximum absorption at 547 nm. Different factors affecting the formation of the ion pair and its stability were studied and optimized in order to obtain the best conditions for the experiment. Method validation was done over a concentration range of 1 to 8 µg/mL. The method was proven to be sensitive with limit for quantitation of 0.93 µg/mL and limit of detection of 0.31 µg/mL. Conclusion: The proposed method was easily and successfully applied for the quantitative determination of atorvastatin in commercial tablets without interference from extractable tablet additives. The sensitivity and cheapness of the method will encourage its use in routine quality control of atorvastatin tablets.

Development and Validation of HPLC Method for the Quantification of Atorvastatin in Pharmaceutical Dosage Forms and Biological Fluid

“…It is available in 10, 20, 40, and 80 mg film-coated tablets. To ensure tablets' quality, safety, and efficacy in formulations, developing a new analytical method for quantitative drug analysis in pharmaceutical dosage forms is crucialThe extensive literature survey was conducted and observed few analytical procedures such as UV-Vis [11][12][13][14][15] , FTIR 16 , X-ray diffraction 17 , FT-Raman spectroscopy 17 , capillary electrophoresis [18][19][20] , Voltammetry [21][22] , TLC [23][24] , HPTLC [25][26] , UPLC [27][28] , LCMS [29][30] and UPLC-MS 27,[32][33] have been reported for the determination of atorvastatin alone or with combination in pharmaceutical dosage forms and biological fluids. The investigation continued with the HPLC technique due to its simplicity, specificity, high sensitivity, and lots of attention in pharmaceutical analysis in dosage forms and biological fluids [34][35][36][37][38] .…”

Development of the spectrophotometric method for the determination of atorvastatin in tablets by using bromothymol blue

“…The disadvantages of the proposed pharmacopoeial method include the long-time of chromatography (85-90 min) and the use of a significant volume of the mobile phase per chromatography. Several analytical methods, including spectrophotometric methods [3][4][5][6][7][8][9][10][11][12] and chromatographic methods [13][14][15][16][17][18][19][20][21][22][23][24][25] have already been reported for its determination, either alone or in combination with other medicines. Ukrainian scientists have developed a spectrophotometric method for the determination of atorvastatin calcium in tablets by reaction with bromocresol purple at a wavelength of 399 nm in acetone [3].…”

“…Ukrainian scientists have developed a spectrophotometric method for the determination of atorvastatin calcium in tablets by reaction with bromocresol purple at a wavelength of 399 nm in acetone [3]. However, the methods of analysis described in the scientific literature often have limited application due to not always sufficient sensitivity, specificity, pH dependence, the need for heating, complexity, durability, use of expensive instruments and toxic reagents (Table 1) [3][4][5][6][7][8][9][10][11]. There were two published analytical methods for determining of atorvastatin calcium either alone [12] and in combination with lisinopril [13], which were developed by our scientific group.…”

Spectrophotometric Studies on the Reaction of Diaveridine with Some Sulfonphthalein Dyes Based on Ion-Pair/Ion-Associate Complexes Formation

“…Sulfonphthaleins are one of the most interesting families of anionic dyes and have attracted scientific attention; this is attributed to their molecular structure which allows formation of ion-associate complexes with various drugs, where ion pair or ion association complexes are those complexes in which the analytical species associates with oppositely charged ions to form neutral compounds [9][10][11][12]. Ion pair complexes formation methods were used for the visible spectrophotometric determination of various drugs in the literature through their ion pairing with oppositely charged dyes to form colored complexes [13].…”