Stability Indicating RP-HPLC Method development and validation for estimation of Dexamethasone in Tablet dosage form.

Stability Indicating RP-HPLC Method development and validation for estimation of Dexamethasone in Tablet dosage form.

Registration ID: IJNRD_223557

Published ID: IJNRD2406197

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Payal Sanjay Bhaskar , Siddhesh Sanjay Bhaskar , Ashwini Arun Wakchaure , Shubha P. Katte , Darshan Vasant Abhang

Dexamethasone, Assay, RP-HPLC, Method validation

Aim: A simple, rapid, accurate and sensitive method was developed for quantitative analysis of dexamethasone in tablet dosage form Using reverse phase high performance liquid chromatography with PDA detection. Materials and Method: The chromatography separation was achieved on Hypersil ODS 250x4.6mm 5μm. At column temperature 25°c±2, in the isocratic mobile phase mode using acetonitrile (ACN): water (52:48; v/v) at a flow rate of 1.0ml/min. The determination was performed using waters HPLC with PDA detector set at 254nm. Samples were prepared with diluent [methanol: water (65:35; v/v)], and the volume injected was 10 µl. The retention time for dexamethasone was 5.24 minute. Results: The analytical curve was linear (r2= 0.9992) over a wide concentration range (50.0-150.0 µg/ml). The presence of excipients of the tablet did not interfere in the results of the analysis. The method showed adequate precision with a relative standard deviation (RSD) less than 2%. The accuracy was analyzed by adding a standard drug and good recovery values were obtained for all drug concentration used. The assay of Dexamethasone was found to be 99.2-101.4%. Conclusion: The HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for quantification of dexamethasone in tablet dosage form. The analytical procedure is reliable and offers advantages in terms of speed and low cost of reagents. Forced degradation studies were performed and the method was validated as per ICH guidelines.

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"Stability Indicating RP-HPLC Method development and validation for estimation of Dexamethasone in Tablet dosage form.", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.9, Issue 6, page no.b963-b971, June-2024, Available :https://ijnrd.org/papers/IJNRD2406197.pdf

Volume 9 Issue 6, June-2024

Pages : b963-b971

Paper Reg. ID: IJNRD_223557

Published Paper Id: IJNRD2406197

Downloads: 000121207

Research Area: Pharmacy

Country: Junnar, Maharastra, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2406197.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2406197

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

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