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, Vikas Chauhan KIET School of Pharmacy, KIET Group of Institutions, Delhi-NCR , Ghaziabad 201206 , India Search for other works by this author on: Oxford Academic Parul Grover KIET School of Pharmacy, KIET Group of Institutions, Delhi-NCR , Ghaziabad 201206 , India Author to whom correspondence should be addressed. KIET School of Pharmacy (KSOP), KIET Group of institutions, Ghaziabad 201206, Uttar Pradesh, India. E-mail: parul.grvr@gmail.com Search for other works by this author on: Oxford Academic Monika Bhardwaj Natural Product and Medicinal Chemistry Division , Indian Institute of Integrative Medicine (CSIR-IIIM), Jammu 180001 , India Search for other works by this author on: Oxford Academic Sandeep Kumar Nims Institute of Pharmacy, Nims University Rajasthan , Jaipur Delhi Highway, Jaipur, Rajasthan, 303121 , India Search for other works by this author on: Oxford Academic K Nagarajan KIET School of Pharmacy, KIET Group of Institutions, Delhi-NCR , Ghaziabad 201206 , India Search for other works by this author on: Oxford Academic
Journal of Chromatographic Science, bmae021, https://doi.org/10.1093/chromsci/bmae021
Published:
04 May 2024
Article history
Received:
25 December 2023
Revision received:
20 March 2024
Revision requested:
15 April 2024
Accepted:
20 April 2024
Published:
04 May 2024
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Vikas Chauhan, Parul Grover, Monika Bhardwaj, Sandeep Kumar, K Nagarajan, Development and Validation of Fast and Sensitive RP-HPLC Stability-Indicating Method for Quantification of Piroxicam in Bulk Drug, Journal of Chromatographic Science, 2024;, bmae021, https://doi.org/10.1093/chromsci/bmae021
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Abstract
A simple, rapid, sensitive, and cost-effective green solvent-assisted reverse-phase high-performance liquid chromatographic technique, coupled with a photodiode array detector, was developed and validated for the estimation of piroxicam (PRXM). The chromatographic separation was achieved by using a C-18 (250 × 4.6) mm, 5-μm stationary phase and a mobile phase consisting of methanol and 0.1% ortho-phosphoric acid in water in a ratio of (80:20) v/v at a flow rate of 1ml/min. The detection was carried out at a wavelength of 254nm with a constant injection volume of 10μL throughout the analysis. The calibration curve was observed to be linear over the optimum concentration range of 50–300μgmL−1, with an R2 value of 0.9995. The developed method was validated as per the International Council for Harmonisation (ICH) Q2 (R1) guideline. Various parameters like selectivity/specificity, accuracy/recovery, linearity, precision, detection limit, quantitation limit, robustness and stability of analyte in solution were performed for the method validation. The PRXM was evaluated under stressed conditions, including acidic, basic, oxidative, thermal and photolytic, as per ICH Q1 (R2) guidelines. Significant degradation was observed in acidic and basic degradation conditions. Conversely, the drug substance showed stability when exposed to oxidative, photolytic and thermal degradation conditions.
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