Quality by design tool evaluated green stability-indicating UPLC content determination method for the Olanzapine and Samidorphan dosage form

Menda, Jyothsna; Chintala, Vaishnavi; Kowtharapu, Leela Prasad; Pydimarry, Surya Prakash Rao; Kanuparthy, Phani Raja; Katari, Naresh Kumar

doi:10.1016/j.microc.2023.109835

Microchemical Journal

2024

DOI: 10.1016/j.microc.2023.109835

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Quality by design tool evaluated green stability-indicating UPLC content determination method for the Olanzapine and Samidorphan dosage form

Jyothsna Menda,

Vaishnavi Chintala,

Leela Prasad Kowtharapu

et al.

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2024

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Cited by 2 publications

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Stability‐indicating RP‐HPLC method development and validation for the quantification of amlodipine besylate and valsartan tablets in solid oral dosage form

Kamireddy,

Sambu,

Lankalapalli

et al. 2024

Biomedical Chromatography

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The present study discusses the development of simple, rapid, specific, precision, accuracy, stability indicating the HPLC method for the analysis of amlodipine besylate and valsartan tablet dosage form. The chromatographic separation was achieved using phosphate buffer with 1% triethyl amine (pH 3.0) as mobile phase‐A and mixed Methanol and buffer in the ratio of (65:35)(v/v) as mobile phase‐B. The detection of components was made at 237 nm for amlodipine besylate and valsartan. Analytical techniques should enrich sensitivity and specificity for the estimation of pharmaceutical drug products. Evaluated stress studies under different types of ICH conditions. The optimized HPLC method was validated as per the current ICH guidelines. The validated HPLC method was obtained highly specific with linearity ranging between 25 and 200 μgmL−1 of amlodipine besylate and 40–320 μgmL−1 of valsartan and both components correlation coefficient was > 0.999. The method showed high accuracy more than 97%. In stress studies, amlodipine besylate and valsartan were found to be sensitive to acid stress conditions and oxidation stress conditions. The method was found to be suitable for the quality control of amlodipine besylate and valsartan in the tablet as well as in stability‐indicating studies. The method was applied to the analysis of stability samples.

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Stability‐indicating RP‐HPLC method development and validation for the quantification of amlodipine besylate and valsartan tablets in solid oral dosage form

Kamireddy,

Sambu,

Lankalapalli

et al. 2024

Biomedical Chromatography

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Development and validation of RP-HPLC method for simultaneous estimation of 5-fluorouracil and silibinin in corn-derived protein-polysaccharide nanocomplex: Forced degradation and mathematical modeling of drug release

Sudhakar Gomte,

Chaturvedi,

Sharma

et al. 2024

Microchemical Journal

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Quality by design tool evaluated green stability-indicating UPLC content determination method for the Olanzapine and Samidorphan dosage form

Cited by 2 publications

References 35 publications

Stability‐indicating RP‐HPLC method development and validation for the quantification of amlodipine besylate and valsartan tablets in solid oral dosage form

Stability‐indicating RP‐HPLC method development and validation for the quantification of amlodipine besylate and valsartan tablets in solid oral dosage form

Development and validation of RP-HPLC method for simultaneous estimation of 5-fluorouracil and silibinin in corn-derived protein-polysaccharide nanocomplex: Forced degradation and mathematical modeling of drug release

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