DAD Based Stability Indicating RP-UPLC Method for Simultaneous Determination of Olmesartan Medoxomil and Amlodipine Besylate

Kerai, Jayshri R.; Vyas, Amitkumar J.; Vihol, Bhupatsinh; Patel, Parth; Patel, Ashok B.

doi:10.1007/s11094-019-01933-0

Cited by 5 publications

(1 citation statement)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…For this reason, the content of amlodipine besylate was reduced by 34.3%. Kerai et al [12] concluded that the decrease in methanol concentration led to the reduction of the degradation of amlodipine besylate. They determined that the content of amlodipine besylate was reduced by 7.9% in 70% (v/v) methanol.…”

Section: Selectivitymentioning

confidence: 99%

Photostability study of amlodipine besylate tablets packed in primary packaging

Savić-Gajić¹,

Savić²,

Sibinović³

et al. 2021

Adv Techol

View full text Add to dashboard Cite

In this study, the modified stability-indicating RP-HPLC method was validated for quantitative analysis of amlodipine besylate in the presence of its impurity D (3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate). The method was applied for the determination of an analyte in the tablets and irradiated samples packed in the primary packaging (Alu/PVC/PVDC blister packaging). The efficient chromatographic separation was achieved using a ZORBAX Eclipse XDB-C18 column (4.6×250 mm, 5 mm) with isocratic elution of mobile phase which consisted of acetonitrile:methanol:triethylamine solution (15:35:50, v/v/v) (pH 3.0). The flow rate of the mobile phase was 1 mL min-1, while the detection of amlodipine besylate was carried out at 273 nm. Amlodipine besylate and its impurity D were identified at the retention times of 16.529 min and 2.575 min, respectively. The linearity of the method with the coefficient of determination of 0.999 was confirmed in the concentration range of 10 - 75 µg mL-1 for amlodipine besylate. The limit of detection was 0.2 µg mL-1, while the limit of quantification was 0.66 µg mL-1. After UV and Vis radiation of the tablets packed in the primary packaging, the content of amlodipine besylate was reduced by 22.38% and 19.89%, respectively. The presence of new degradation products was not detected under the given chromatographic conditions. The photodegradation of amlodipine besylate followed pseudo-first-order kinetics. Based on the half-life of amlodipine besylate (38.4 days for UV radiation and 43.3 days for Vis radiation), it was concluded that amlodipine besylate in the tablets has satisfactory photostability after its packing in the Alu/PVC/PVDC blister packaging.

show abstract

Section: Selectivitymentioning

confidence: 99%

Photostability study of amlodipine besylate tablets packed in primary packaging

Savić-Gajić¹,

Savić²,

Sibinović³

et al. 2021

Adv Techol

View full text Add to dashboard Cite

show abstract

Simultaneous Determination of Amlodipine and Olmesartan Using HPLC with Fluorescence Detection

et al. 2021

View full text Add to dashboard Cite

A sensitive, simple and rapid RP-HPLC method with fluorescence detection has been developed to simultaneously quantify amlodipine besylate (AML) and olmesartan medoxomil (OLM) in their combined pharmaceutical preparation. The method development was divided into three phases. In the first phase, a Plackett-Burman design (PBD) was used to screen five independent factors. The objective of the second phase was to optimize the method performance using a single factor design to obtain the best chromatographic performance for a short run time. Optimum separation was obtained using Lichrospher RP-18 (250 mm ´4.6 mm ´5 mm) column in the isocratic mode using a mobile phase of methanol and 5mM sodium dihydrogen phosphate buffer pH 2.5 (60:40, v/v). The flow rate was maintained at 1.2 mL/min and the detection was performed with a fluorescence detector set at 417 nm (l emission ) after excitation at 254 nm (l excitation ). The third phase was method validation according to ICH guidelines. The method was valid in a concentration range of 175 -325 ng/mL for AML and 250 -1750 ng/mL for OLM. The proposed method was successfully applied for analysis of the binary mixture of two drugs in their combined pharmaceutical formulation.

show abstract