Simultaneous determination of rosuvastatin and amlodipine in human plasma using tandem mass spectrometry: Application to disposition kinetics

Abstract

The liquid chromatography–tandem mass spectrometric assay method for the simultaneous determination of rosuvastatin and amlodipine in human plasma using deuterated analogs as internal standards has been developed and validated. The analytes were extracted from 100 μL aliquots of human plasma via liquid–liquid extraction using a mixture of ethyl acetate and n-hexane (80:20, v/v) as an extraction solvent. The optimized mobile phase was composed of 0.1% formic acid in 5 mM ammonium acetate, methanol, and acetonitrile (20:20:60, v/v/v) and delivered at a flow rate of 0.75 mL/min. The calibration curve obtained was linear (R2 ⩾ 0.999) over the concentration range of 0.52–51.77 ng/mL for rosuvastatin and 0.10–10.07 ng/mL for amlodipine. A sample turnover rate of less than 2.5 min makes it an attractive procedure in high-throughput bioanalysis of rosuvastatin and amlodipine. The present method was found to be applicable to clinical studies and the results were authenticated by incurred sample reanalysis.

Analytical Methods for the Determination of Rosuvastatin in Pharmaceutical Formulations and Biological Fluids: A Critical Review

“…However, other analytical and bioanalytical methods demonstrated higher sensitivity values ranging from 0.05 mg/mL to 30 mg/ mL. Table 4 [56,[108][109][110][111][112][113][114][115][116][117][118][119][120][121][122][123][124][125] shows the LC-MS/MS methods developed for ROS analysis alone or in combination with other drugs determined in biological fluids. Most LC-MS/MS analyses were performed in positive ion mode (ESI C ) for the quantification of ROS in human plasma.…”

A simple, rapid and fully validated HPLC method for simultaneous quantitative bio‐analysis of rosuvastatin and candesartan in rat plasma: Application to pharmacokinetic interaction study

“…A literature review revealed several bio‐analytical methods reported for ROS (Braga, Mancila, Cassella, & Pacheco, ; Caglar & Toker, ; Darwish & Al‐malaq, ; J. Gao, Zhong, Duan, & Chen, ; C K Hull, Penman, Smith, & Martin, ; Caroline K. Hull, Martin, Warwick, & Thomas, ; Hussain, Patel, & Tan, ; Kallem, Karthik, Chakradhar, & Mullangi, ; T. R. Kumar et al, ; Lan et al, ; H. K. Lee, Ho, Hu, Tomlinson, & Wong, ; MacWan, Ionita, & Akhlaghi, ; Oudhoff, Sangster, Thomas, & Wilson, ; Xu, Ruan, Yuan, & Jiang, ) and CAN (Gao et al, ; Jeon et al, ; Kondo, Yoshida, Yoshimura, Motohashi, & Tanayama, ; J. W. Lee et al, ; Lou, Ruan, & Jiang, ; Miyabayashi, Okuda, Motohashi, Izawa, & Yashiki, ; Prajapati, Patel, Chauhan, Patel, & Patel, ; Stenhoff, Lagerström, & Andersen, ) individually or in combination with other drugs like pioglitazone, hydrochlorothiazide, ciprofloxacin, metformin, etc., using either HPLC or LC–MS/MS (Arayne, Sultana, & Tabassum, ; Pp. Kumar, Murthy, & Basaveswara Rao, ; Narapusetti, Bethanabhatla, Sockalingam, Repaka, & Saritha, ; Nasir et al, ; Shah et al, ; Trivedi, Kallem, Mullangi, & Srinivas, ; Varghese & Ravi, ; Vittal et al, ; Bharathi, Hotha, Chatki, Satyanarayana, & Venkateswarlu, ; Gonzalez, Lopez, Alonso, & Jimenez, ; Kumari Karra, Rao Pilli, Kumar Inamadugu, & Seshagiri Rao, ; Nie et al, ; Singh, Lokhandae, Dwivedi, Sharma, & Dubey, ).…”

Development and Validation of a Method for the Simultaneous Quantification of Aspirin, Salicylic Acid, Rosuvastatin, Rosuvastatin Lactone and N-Desmethyl Rosuvastatin in Human Plasma Using UPLC-MS/MS-API-5500

“…Literature survey shows that RP-HPLC stability indicating methods for rosuvastatin alone or with combination [2], LC-MS/MS methods for plasma for rosuvastatin alone or with metabolites/combination of other drugs [3][4][5][6][7][8][9][10][11][12][13][14][15][16], LC-MS/MS methods for plasma for aspirin alone or with metabolites/combination of other drugs [17][18][19][20][21][22][23][24][25] are reported. It is noted that method for simultaneous estimation of RVT with metabolites and ASP with metabolite is not available.…”

“…Potassium fluoride was used as a stabilizer, to prevent the hydrolysis of ASP to SLA while L-ascorbic acid is used to as stabilizer to prevent the inter conversion between RVT to RVL and vice versa. We had used switch over polarity concept [26] in single method, to achieve required sensitivity and selectivity. SPE method was used to clean up the plasma samples, to avoid the matrix effect and to achieve maximum recovery.…”