Simultaneous determination of bisoprolol fumarate and rosuvastatin calcium in a new combined formulation by validated RP-HPLC

Abstract

A simple, specific, and precise RP-HPLC method was developed and validated for simultaneous determination of Bisoprolol fumarate (BIS) and Rosuvastatin calcium (ROS) in new formulated tablets. The developed RP-HPLC method depended on chromatographic separation using C18 column (150×4.6 mm, 0.5 μm) with mobile phase consisted of acetonitrile and 0.05 aqueous solution of orthophosphoric acid at the ratio of 65:35 % (v:v) with a flow rate of 1 mL/min and UV detection was carried out at 230 nm. Factors affecting the developed methods were studied and optimized and the retention times for BIS and ROS were found to be 2.758 and 4.974 min, respectively. Linearity of the proposed method was observed over a concentration range 0.2-50 μg/mL for each of BIS (r = 0.9999) and ROS (r = 0.9998). The proposed method was successfully applied for the determination of the studied drugs in their bulk powder, laboratory prepared mixtures and in the formulated tablets. The developed method is the first chromatographic method for determination of those drugs and showed no significant difference when compared with the reported methods.

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“…The present study envisages developing and validating the Q-absorbance UV-spectrophotometric method for simultaneously estimating BF and CLD in their tablet formulation. Determination of BF alone and in combinations with other drugs is reported in the literature by various methods, that is, UV Spectrophotometry, [6][7][8][9] HPTLC, [10][11][12] HPLC, [13][14][15][16][17][18][19] and capillary electrophoresis. [20][21][22] Furthermore, determination of CLD alone or with other drugs by HPTLC, [23][24][25][26][27][28] HPLC, [29][30][31][32][33][34] and spectrophotometry [30,[35][36][37][38][39][40][41][42][43][44][45] is reported.…”

Analytical Methods for Determination of Certain Antihypertensive Drugs

“…The developed RP-HPLC method depended on chromatographic separation using C 18 column (150 × 4.6 mm, 5 μm) with mobile phase consisting of acetonitrile and 0.05 aqueous solution of orthophosphoric acid at the ratio of 65:35 % (v:v) with a flow rate of 1 mL/min and UV detection at 230 nm [154]. HPTLC method was used for simultaneous determination of bisoprolol and hydrochlorothiazide in pharmaceutical dosage forms.…”

Accelerated Stability Indicating LC Method for Simultaneous Quantification of Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate

“…An extensive literature review revealed that various analytical methods like the RP‐HPLC pharmacopoeial method [3], spectrofluorimetric method [4, 5], RP‐HPLC [6–8], UPLC [9], HPTLC [10], LC‐MS [11, 12], and HS‐GC‐FID [13] methods are reported for DPM alone, and UV [14–25], RP‐HPLC [26–45], UPLC [46–48], HPTLC [43, 44, 49–57], LC‐MS/MS [45, 58, 59], and CE [60] methods are reported for DPM with other drugs. Pharmacopoeial methods [61–63], UV [64–68], RP‐HPLC [69–72], LC‐MS [73, 74], LC‐MS/MS [75], and UPLC‐MS/MS [76] methods are reported for BF alone, and spectrofluorimetric methods [77], UV [78–85], RP‐HPLC [86–97], UPLC [98], LC‐MS/MS [99], and HPTLC [100–104] for BF with other drugs. Both drugs have been estimated individually and with other drugs, but as it is a recently approved combination, no analytical method is available for simultaneous quantification of DPM and BF.…”