Determination of Letrozole in Tablet Formulations by Reversed Phase High Performance Liquid Chromatography

Abstract

Purpose: To develop a simple, rapid, accurate and cost-effective reversed phase high performance liquid chromatography (RP-HPLC) method for letrozole in bulk and in tablets. Methods: Development of a method for the determination of letrozole, an anti-cancer drug, by RP-HPLC was undertaken using a new mobile phase of acetonitrile:water (50:50, v/v). The eluent was monitored at 265 nm. Results: The optimized conditions developed showed a linear response from 160 to 240 µg/mL, with a correlation coefficient (R 2 ) of 0.999. The limit of detection (LOD) and limit of quantification ( LOQ) were 136 and 160 µg/mL, respectively. The assay values for the two branded letrozole tablets tested were 99.2 and 100.2 %, respectively with % relative standard deviation (RSD) of 0.781 and 0.568, respectively. The bench top stability data of the drug in the mobile phase indicate that the drug was stable in the mobile phase for 24 h. Recovery data were good. Placebo study for specificity and interference of common excipients showed that the method was specific and free from interfering substances. Conclusion: Therefore, the fully validated method developed was sensitive enough to carry out routine analysis of letrozole in tablet formulations with regard to its run time, simplicity of sample preparation and accuracy.

Evaluation of the pharmacokinetics of the simultaneous quantification of letrozole and palbociclib in rat plasma by a developed and validated HPLC–PDA

“…First of all, spectrometric methods were applied on LTZ dosage forms [15][16][17], and the highest sensitivity among them was linear in the range 0.25 to 20 μg/mL [17]. Different high-performance liquid chromatography-UV detection (HPLC-UV) methods are reported to determine LTZ in pharmaceutical dosage forms [18][19][20][21][22][23][24][25][26]. The best sensitivity among those methods was reported by Mondal et al, [24] ranging from 1 to 50 μg/mL, and the limit of detection (LOD) and limit of quantification (LOQ) were 0.207 μg/mL and 0.627 μg/mL, respectively.…”

Magnetic iron oxide nanoparticles graftedN-isopropylacrylamide/chitosan copolymer for the extraction and determination of letrozole in human biological samples

“…The degree of LE sorption on MNPs-CS-NIPAM was investigated at various ranges of pH values (3)(4)(5)(6)(7)(8). As shown in Fig.…”

“…In postmenopausal women, LE blocks the estrogen‐producing process so decreases the amount of estrogen in the body. In this condition, tumor growth becomes more slowly or stops .…”

A descrição teórica da detecção eletroanalítica do letrozol, assistida pelo compósito VO(OH)-polipirrol, obtido catodicamente

“…O seu uso excessivo em mulheres pode provocar a síndrome de hiperestimulação ovariana [9,10]. Ademais, o seu uso duradouro e excessivo pode provocar osteoporose [11]. Destarte, o desenvolvimento de métodos da sua determinação é, deveras, uma tarefa atual [12][13][14], e o desenvolvimento de métodos eletroquímicos servir-lhe-iam de boa solução.…”