A Validated Stability Indicating RP-UPLC Method for Atrovastain Calcium

Kumar, Kakumani Kishore; Rao, Chimalakonda Kameswara; Lakshmi, M. Vijaya; Mukkanti, K.

doi:10.4236/ajac.2012.35052

Cited by 12 publications

(7 citation statements)

References 7 publications

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“…The degradation study of atorvastatin (ATV) was investigated by some researchers with a various method such as liquid chromatography-mass spectroscopy (LC-MS) [16], ultra performance liquid chromatography (UPLC) [17][18][19], and highperformance liquid chromatography (HPLC) [20][21][22][23][24]. Lakka et al conducted stress tests on ATV with HPLC method.…”

Section: Force Degradation Study Of Atorvastatinmentioning

confidence: 99%

Forced Degradation Study of Statins: A Review

2018

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Forced degradation study is the degradation of new drug substances and drug products in more severe conditions than accelerated conditions. Forced degradation study were conducted to demonstrate the specificity of stability-indicating methods, providing insight into degradation pathways and drug degradation products, assisting in the elucidation of degradation product structures, identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies. Statins, a class of lipid-lowering medications, are the most widely prescribed drugs and an example of an unstable drug. Statins are susceptible to hydrolysis in the presence of high temperatures and humidity. Therefore, the review discusses various studies of forced degradation studies in six statins drug (atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin) to describe the drug's intrinsic stability thus it can assist the selection of formulations and packaging as well as proper storage conditions.

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Section: Force Degradation Study Of Atorvastatinmentioning

confidence: 99%

Forced Degradation Study of Statins: A Review

2018

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“…Literature survey revealed that the published chromatographic methods intended to be used for this aim were quite rare. Reviewing literature revealed that atorvastatin and lisinopril were determined by HPLC methods [5–26] in mono drugs or combined drugs (atorvastatin + amlodipine, atorvastatin + nicotinic acid, atorvastatin + ramipril + aspirin, atorvastatin + aspirin + clopidogrel, amlodipine + lisinopril, etc.). Only two methods reported the simultaneous determination of atorvastatin and lisinopril, namely, an HPLC method [27] and a MEK method [28].…”

Section: Introductionmentioning

confidence: 99%

Chaotropic salts impact in HPLC approaches for simultaneous analysis of hydrophilic and lipophilic drugs

Shulyak

Piponski²,

Коваленко

et al. 2021

J of Separation Science

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Simultaneous determination of drugs with different physicochemical properties necessitates thorough research and careful selection of high‐performance liquid chromatography conditions. In the present study, various concepts of high‐performance liquid chromatography method development for this aim have been discussed. Moreover, the work was motivated by the advantages of utilizing different chaotropic anions as a new promising approach to overcome the limitations of ion‐pairing agents commonly used for this purpose. Based on log P values, atorvastatin (log P = 6.36) and lisinopril (log P = –1.22) were chosen as representative examples for lipophilic and hydrophilic drugs, respectively. Several simple, economic, fast, and reliable high‐performance liquid chromatography methods were developed for their simultaneous analysis and are presented in a comparative manner, highlighting their advantages and limitations. Peak elution profile showed satisfying retentions and resolution about 3. Photo‐diode array calculations were exploited for identifying the molecules by their ultra‐violet spectra and peak purity, calculated and presented as rectangular‐shaped ratio grams. The linearity check showed excellent results and satisfactory system suitability parameters of both peaks. This confirms the investigation results and conclusions for the influence of the chaotropic salts on N‐containing molecules, by increasing their retentivities, and improving peak shapes, even on different quality columns without end‐capping and base‐deactivating of separation matrixes.

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“…This will shorten the column life and use. In spite of the pharmacopoeial method, there are also a few published HPLC analytical methods for the quantification of atorvastatin in combination with other active substance [4][5][6][7][8][9][10][11][12][13], or for the determination of atorvastatin alone, or together with its impurities [14][15][16][17][18][19][20][21], with UV detection. We found the articles published by Petkovska et al [18] and Vakkum et al [20] as the most applicative and useful for testing atorvastatin impurities.…”

Section: Introductionmentioning

confidence: 99%

Development of a Novel, Fast, Simple HPLC Method for Determination of Atorvastatin and its Impurities in Tablets

Shulyak

Piponski²,

Коваленко

et al. 2021

Sci. Pharm.

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Our main target and concept was to develop a method for the determination of the most prescribed antilipemic drug, atorvastatin, together with its related substances, with a single sample preparation and during a single chromatographic run, in the shortest possible period of time, with the lowest possible mobile phase consumption. A new rapid, simple chromatographic method for the determination of atorvastatin and its main specified impurities was developed, using different chromatographic columns. With this new concept of a mobile phase and a powerful core–shell, or a superficially porous silica-based column, satisfactory results for targeted parameters, such as critical peak resolution, run time length, and column backpressure, were achieved. The analysis is performed within a run duration of less than 15 minutes, which is about six times shorter than the official European Pharmacopoeia method. The chromatogram performances suggests that the method limit of quantification (LOQ) can be about 7 times lower, and the limit of detection (LOD) about 20 times lower, using an injection volume of only 2 µl. This was confirmed by the performed method validation in accordance with the International Conference on Harmonization (ICH) guideline for the validation of analytical procedures Q2(R1), where the selectivity, linearity, accuracy, precision, limit of quantification, and limit of detection were tested and confirmed.

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A Validated Stability Indicating RP-UPLC Method for Atrovastain Calcium

Cited by 12 publications

References 7 publications

Forced Degradation Study of Statins: A Review

Forced Degradation Study of Statins: A Review

Chaotropic salts impact in HPLC approaches for simultaneous analysis of hydrophilic and lipophilic drugs

Development of a Novel, Fast, Simple HPLC Method for Determination of Atorvastatin and its Impurities in Tablets

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