Development and Validation of Stability Indicating Rp-HPLC Method for the Simultaneous Estimation of Rosuvastatin and Ezetimibe in Combined Dosage Form

Sireesha, D

doi:10.20959/wjpr20178-9160

Cited by 3 publications

(1 citation statement)

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“…Reference 13 , here, drug is highly unstable under thermal thermal degradation (20%) and acidic hydrolysis (16%). It was found to be stable under neutral hydrolysis.…”

Section: Fig 3: Forced Degradation Study Of Drug Substance and Drug P...mentioning

confidence: 99%

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2023

IJPSR

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Rosuvastatin is a widely used lipid-lowering medication that belongs to the class of "Statins" whereas Teneligiptin is a novel potent drug that belongs to the class of "DPP-4 inhibitors" which is used for the treatment of Type 2 Diabetes mellitus. The FDA recently approved the combination of these two drugs in 2021 since it proved to be highly effective for treating dyslipidemia associated with Type 2 Diabetes mellitus. Forced degradation studies have been performed on Rosuvastatin and Teneligliptin separately using various analytical techniques such as RP-HPLC, UV, RP-UFLC, RP-UPLC, UHPLC, HPTLC and TLC. Characterization of the degradation products generated during various stress conditions is also performed using various sophisticated techniques such as UPLC, LC/MS/MS, NMR, and FT-IR. These degradants can cause many adverse effects, such as carcinogenicity, mutagenicity, neurotoxicity, hepatotoxicity, skin sensitization, respiratory sensitization, etc. So, identifying and characterizing these degradation products will be very useful for their metabolic studies and in-silico toxicity assessment. In-silico toxicity studies are very helpful in predicting the toxic potential of these degradants, and it is performed using various software such as TOPKAT, Osiris, and DEREK. Thus, the present review aims to summarise the forced degradation studies as well as characterization of the degradation products generated from both rosuvastatin and teneligliptin using various modern analytical techniques so that it will significantly contribute in the future regarding their metabolic studies, determination of impurities during their bulk synthesis as well as toxicity predictions.INTRODUCTION: Degradation can be defined as the incapability of a particular substance to remain within its particular physical, chemical, microbiological, toxicological, and therapeutic specifications. "Forced degradation can be defined as the degradation of a New drug substance or new drug product at conditions more severe than the accelerated conditions.

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“…Reference 13 , here, drug is highly unstable under thermal thermal degradation (20%) and acidic hydrolysis (16%). It was found to be stable under neutral hydrolysis.…”

Section: Fig 3: Forced Degradation Study Of Drug Substance and Drug P...mentioning

confidence: 99%

Untitled

2023

IJPSR

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Development and Validation of HPLC Method for Simultaneous Estimation of Minoxidil and Finasteride in Topical Solution

Shradha S. Deshmukh,

Ajwitas Kale

2023

IJARSCT

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A simple, precise, rapid, accurate HPLC method has been developed and validated for the simultaneous determination of Minoxidil and Finasteride in pharmaceutical dosage form. The chromatographic separation was achieved on ODS C18 column (250mm*4.6mm,5 micrometer particle size) using a mobile phase comprising Buffer(7.0PH); ACN 80:20% v/v. The flow rate was 1ml/min and eluents were detected by UV detector at 210 nm. Retention times were found to be 2.967 min and 5.750 min Finasteride and Minoxidil respectively. The calibration curve was linear over the range of 20-80 microgram/ml of Minoxidil and 0.5 -1.6 microgram/ml of Finasteride. The developed method was successfully applied for determination of the two drugs from its pharmaceutical formulation. The excipients in the formulation do not pose any hindrance in determination of two drugs. The proposed method is suitable for routine quality control analysis

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A new stability indicating RP-UFLC method for the simultaneous estimation of Ezetimibe and Rosuvastatin combined dosage forms (Tablets)

Chandrakant Kulkarni,

Sunil Dadhich,

Mathrusri Annapurna

2023

RJPT

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The combination of Ezetimibe and Rosuvastatin is used for lowering the cholesterol along with proper diet. A new stability indicating RP-UFLC method has been developed and validated for the estimation of Ezetimibe and Rosuvastatin in tablet dosage forms. Shimadzu Model CBM-20A/20 Alite UFLC system with Phenomenex C18 column (PDA detector) was used for the present chromatographic study. Both the drugs obeyed Beer-Lambert’s law over the concentration range 0.1-150 mg/ml and the linear regression equations are found to be y = 43364x + 8195.5 and y = 49468x – 7194 (R² = 0.9999) (R² = 0.9999) Ezetimibe and Rosuvastatin respectively. The LOD and LOQ values were found to be 0.0287 mg/ml and 0.0957 mg/ml for Ezetimibe and for that of Rosuvastatin the LOD and LOQ values were found to be 0.0291 mg/ml and 0.0892 mg/ml for respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines.

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Development and Validation of Stability Indicating Rp-HPLC Method for the Simultaneous Estimation of Rosuvastatin and Ezetimibe in Combined Dosage Form

Cited by 3 publications

References 1 publication

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Development and Validation of HPLC Method for Simultaneous Estimation of Minoxidil and Finasteride in Topical Solution

A new stability indicating RP-UFLC method for the simultaneous estimation of Ezetimibe and Rosuvastatin combined dosage forms (Tablets)

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