A Review: Method Development Validation and Degradation Studies of some Anticancer Drugs

Venkateshwarlu, Punna; Patel, Mehul

doi:10.52711/0974-360x.2021.00949

Cited by 5 publications

(1 citation statement)

References 43 publications

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“…In this calculation, σ represents the standard deviation of response and S is the slope of the calibration curve. [16][17][18] Studies on forced degradation Analysis of all forced degradation trials was done at the concentration level of 10 µg/mL. The drug solution was treated with 1-mL of 0.1N HCl for acid degradation, 1-mL of 1N NaOH for alkaline degradation, and 1-mL of 10% H 2 O 2 for oxidative degradation.…”

Section: Limit Of Detection and Limit Of Quantitationmentioning

confidence: 99%

Development of Novel RP-HPLC Method for Estimating Tepotinib in Bulk and Pharmaceutical Dosage Form

Kumbhar,

Kokare,

Digge

2023

IJPQA

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Objective: The study’s goal is to develop a highly appropriate, fast, precise, and validated reverse-phase high-performance liquid chromatography (RP-HPLC) approach that indicates stability for the estimation of tepotinib in pharmaceutical dosage form and bulk, in accordance with ICH recommendations. Method: The components were separated by chromatography using a Phenomenex Kinetex XB-C18 (150×4.6 mm, 5μ) column. The absorbance was measured at 272 nm, and the flow rate was 1.0 mL̸min. The International Council for Harmonisation (ICH) states that checks were made for linearity, precision, accuracy, system appropriateness, specificity, and protocol robustness. Results: Tepotinib was shown to have a retention period of 3.4 minutes. The results showed that the linearity ranged from 5 to 25 μg/mL (r2 = 0.9993), and the percentage mean recoveries for tepotinib’s accuracy and precision fell within the range of (%RSD˂ 2). It was discovered that the Limit of Detection (LoD), and Limit of Quantitation (LoQ) were, respectively, 0.429 and 1.3 μg/mL.

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Section: Limit Of Detection and Limit Of Quantitationmentioning

confidence: 99%

Development of Novel RP-HPLC Method for Estimating Tepotinib in Bulk and Pharmaceutical Dosage Form

Kumbhar,

Kokare,

Digge

2023

IJPQA

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Development and Validation of UV Spectrophotometric Method for Determination of Tepotinib in Bulk and Pharmaceutical Dosage Forms

Kumar,

Mrs.S.Marakatham,

Polampalli

et al. 2024

Preprint

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The aim of this study was to develop a new, rapid and highly sensitive UV spectrophometer method for the Tepotinib bulk drug. The mobile phase consisted of Water & Acetonitrile in the ration of 50:50v/v and the wavelength to maximum absorbance at 256.0 nm. Analytical calibration curves were linear within a concentration range from 2.5 to 15µg/ml and coefficient of correlation 0.999. %RSD was found to be less than 2. The result of analysis has been validated statistically. This method will be validated in accordance with ICH requirements included the linearity, precision, accuracy sensitivity, and specificity. Hence the proposed method can be used for the reliable quantification of Tepotinib in tablet formulation.

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Development and Validation of Novel Uv-Visible Spectrophotometric Method for Estimation of Tepotinib in Bulk and in Pharmaceutical Formulation

SHIRWAR,

BIRAJDAR,

GARAD

et al. 2023

Int J Pharm Pharm Sci

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Objective: The objective of the study is to develop a new, simple, rapid, accurate, and economical UV-spectrophotometric method and validate the same for the estimation of Tepotinib in bulk and in pharmaceutical formulation as per ICH guidelines. Methods: The present work was carried out using the UV-Visible double-beam spectrophotometer model Systronics 2201. Tepotinib was found soluble in water, methanol, methanol so, analytical-grade methanol was used as a solvent for conducting the work. The λmax of the tepotinib was determined by dissolving pure drug in methanol scanned in the range of 200-800 nm. The present method was validated for the linearity, accuracy, precision, Limit of Detection and Limit of Quantification. Results: The maximum absorbance of tepotinib obtained at a wavelength of 272 nm. The method was found linear in the range of 3-15 µg/ml with the regression coefficient of 0.996 and the equation y = 0.0699x+0.0335. The accuracy was found to be in the range of 96.8-98.5%, the intra-day and inter-day precision % RSD value was 0.262 and 0.69, respectively and the LOD and LOQ were 0.0925 µg/ml and 0.28 µg/ml respectively. Conclusion: The method demonstrated good reproducibility and recovery so, proposed method can be successfully applied for the routine analysis of tepotinib in bulk and pharmaceutical dosage form.

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A Review: Method Development Validation and Degradation Studies of some Anticancer Drugs

Cited by 5 publications

References 43 publications

Development of Novel RP-HPLC Method for Estimating Tepotinib in Bulk and Pharmaceutical Dosage Form

Development of Novel RP-HPLC Method for Estimating Tepotinib in Bulk and Pharmaceutical Dosage Form

Development and Validation of UV Spectrophotometric Method for Determination of Tepotinib in Bulk and Pharmaceutical Dosage Forms

Development and Validation of Novel Uv-Visible Spectrophotometric Method for Estimation of Tepotinib in Bulk and in Pharmaceutical Formulation

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