Development and validation of a spectrophotometric method for estimation of letrozole in bulk and pharmaceutical formulation
Open accessAbstract
A simple, sensitive and accurate UV spectrophotometric method has been developed for the determination of letrozole, a new aromatase inhibitor, in raw material and tablets. The drug shows maximum absorption at 238 nm. Beer's law was obeyed in the concentration range 2–20 μg/mL for the drug. Results were validated statistically according to ICH guidelines. Validation of the method yielded good results concerning range, linearity, precision and accuracy. It was found that the excipients present in the commercial formulation did not interfere with the method.
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Previously reported spectrophotometric methods are not very sensitive and accurate to quantify LTZ in low concentrations.
“Previously, a few spectrophotometric methods have been developed to estimate LTZ; however, these methods are not very sensitive and accurate to quantify LTZ in low concentrations (Mondal et al. 2007; Ganesh et al. 2007; Ganesh et al. 2008).”
From A simple, precise, and sensitive HPLC method for quantification of letrozole in rat plasma: development, validation, and preclinical pharmacokinetics (2021) · cites this paper as Mondal et al. 2007
The Abstract (page not provided) describes this paper’s UV spectrophotometric method as sensitive and accurate, with a validated concentration range of 2–20 mg/mL, rather than characterizing it as insufficiently sensitive or accurate. The Introduction (page not provided) also says its literature survey found no earlier UV spectrophotometric method for letrozole in pharmaceutical formulations; it does not support the claim about a few earlier methods. (LLM, conf=0.87)
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Research works printed but not linked: 2
- Budavari S (ed.) (2001) The Merck Index, An Encyclopedia of Chemicals, drugs and biologicals, Merck and Co., 13th Edn, White house Station, NJ, 974.
- Gu P, Li Y, Wu Y, Jiang S (2001) Determination of letrozole and related substances in tablets by TLC and HPLC. Zhongguo Yiyao Gongye Zazhi 32: 317-318. International Conference on Harmonization (ICH) of Technical Require- ments for Registration of Pharmaceuticals for Human Use: Harmonized Tripartite Guideline on Validation of Analytical Procedures: Methodo- logy Recommended for Adoption at step 4 of the ICH process on November 1996 by the ICH Steering Committee, Published by IFPMA, Switzerland.
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Acharjya, S., Mallick, P., Panda, P., Kumar, K., & Annapurna, M. (2010) · Journal of Advanced Pharmaceutical Technology & Research · doi:10.4103/0110-5558.72425 · Cited by 46 · see citing works
“On a detailed literature survey, it was found that letrozole could be estimated by spectrophotometry,[3-4] Highperformance liquid chromatography (HPLC),[5-10] the microarray approach,[11] capillary gas chromatographic method with flame ionization detector,[12] and by gas chromatography – mass sprectrometry (GC / MS)[1…”
MethodShawky, A. M., & El-Tohamy, M. F. (2021) · Polymers · doi:10.3390/polym13091384 · Cited by 34 · see citing works
Hegde, A. R., Padya, B. S., Soman, S., & Mutalik, S. (2021) · Journal of Analytical Science and Technology · doi:10.1186/s40543-021-00276-4 · Cited by 17 · see citing works
“Previously, a few spectrophotometric methods have been developed to estimate LTZ; however, these methods are not very sensitive and accurate to quantify LTZ in low concentrations (Mondal et al. 2007; Ganesh et al. 2007; Ganesh et al. 2008).”
Method
- Authors
- Mondal, N., Pal, T. K., & Ghosal, S. K.
- Affiliations
- Jadavpur University (IN)
- Venue
- Die Pharmazie
- Publisher
- IMR Press
- Published
- 2007-08-01
- Volume
- 62
- Issue
- 8
- Pages
- 597-8
- ISSN
- 0031-7144 (ISSN-L)
- 3053-691X
- OpenAlex
- W7156612757
- Cited by
- 21
- References
- 0
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 2 · 2022: 1 · 2021: 3 · 2020: 2 · 2017: 4 · 2016: 1 · 2015: 2 · 2012: 2
- FWCI
- 0.34
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Die Pharmazie (publishedVersion, cc-by)
- PubMed (publishedVersion)
- PubMed
- Funders
- Sun Pharma
- Topics
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical chemistry methods development
- Keywords
- letrozole, aromatase inhibitors, UV spectrophotometric determination, pharmaceutical tablet analysis, pharmaceutical analysis, method validation, excipient interference
- MeSH terms
- Letrozole, Antineoplastic Agents, Chemistry, Pharmaceutical, Chromatography, High Pressure Liquid, Chromatography, Thin Layer, Gas Chromatography-Mass Spectrometry, Nitriles, Reference Standards, Spectrophotometry, Ultraviolet, Tablets, Triazoles, Reproducibility of Results
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