Development and validation of rp-hplc method for the estimation of acyclovir in API and tablet formulation

Matole, Vinod; Thorat, Yogesh; Javalgikar, Akshay; Jamakhandi, Shraddha; Pawar, P.B.

doi:10.5958/2231-5675.2021.00008.9

Cited by 2 publications

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“…The physical characteristics like practical solubility, melting point, and IR interpretation of the Molnupiravir were performed before starting method development (Tables 1-3 and Figure 1). [7][8][9][10]…”

Section: Analysis Of Physical Characteristicsmentioning

confidence: 99%

New Stability Indicating RP-HPLC Method for Estimation of the Drug Molnupiravir

Deshpande¹,

Shaikh²,

Sable³

et al. 2023

IJPQA

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Background: Molnupiravir was granted approval by the UKS medicines and health product regulatory agency on 04 November 2021 and on 23 December 2021, granted emergency use of authorization by FDA. Objective: Provide a technique for measuring Molnupiravir in active pharmaceutical ingredients and formulations. Method: The wavelength maximum was found to be 236 nm. ICH guidelines were followed. The forced degradation study in the form of acidic, alkali, thermal, photolytic, hydrolytic, and oxidative stress conditions was carried out for Molnupiravir. Results: The method was linear, as measured by a coeffi cient of correlation (R2) of 0.9991 in the 10 to 50 μg/mL range. The %RSD for precision, accuracy, limit of detection (LoD), limit of quantitation (LoQ), ruggedness, and robustness was within acceptable limits per ICH Q2 (R1). Conclusion: HPLC equipped with a UV detector is used to create and verify the proposed method. An acetonitrile mobile phase component of 20% was used, demonstrating the more cost-eff ective technique. The extensive data of mobile phase optimization gives a complete idea of fi nal chromatographic conditions, which can be further implemented for future analysis. Molnupiravir shows less than 4% degradation under diff erent stress conditions. The forced degradation data helps show stability, indicating the behavior of Molnupiravir.

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Section: Analysis Of Physical Characteristicsmentioning

confidence: 99%

New Stability Indicating RP-HPLC Method for Estimation of the Drug Molnupiravir

Deshpande¹,

Shaikh²,

Sable³

et al. 2023

IJPQA

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“…The recovery tests were done 3 times. The method's accuracy was determined by calculating drug recoveries using the standard addition method to determine if the excipients in the formulation developed any positive or negative interference as shown in Tables 6 and 7 [26].…”

Section: Accuracymentioning

confidence: 99%

Response Surface Method for the Simultaneous Estimation of Atorvastatin and Olmesartan

et al. 2022

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The simultaneous estimation of Atorvastatin Calcium (ATS) and Olmesartan Medoxomil (OLM) in bulk and pharmaceutical dosage forms, a new, quick, and cost-effective Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed. The experimental design was used to achieve multivariate optimization of the RP-HPLC experimental conditions. Three independent variables were used to create mathematical models: Acetonitrile content in the mobile phase composition, buffer pH, and flow rate. Here, the applied model was central composite design (CCD) to research the response surface methodology and study the effects of independent factors. The Shimadzu (LC 20 AT VP) HPLC system with Spinchrom software has been used. Zodiac, C18 (250×4.6 ID) 5μm column, phosphate buffers, and acetonitrile were used as mobile phase in the ratio 40:60 v/v with a flow rate 1.15 mL/min. The eluent was monitored at 212 nm using the Prominence UV-Visible detector. The retention time for OLM and ATS was 2.673 and 3.717, respectively. The optimized procedure was validated as per ICH guidelines. The correlation coefficient of OLM and ATS was 0.9869 and 0.9832. The % of recovery was 98.59, 99.68 %. OLM had a LOD of 17.568 μg/mL, while ATS had a LOD of 12.88 μg/mL. OLM had a LOQ of 53.24 μg/mL, while ATS had a LOQ of 39.04 μg/mL. The pH aqueous phase, solvent composition, and flow rate were the most stringent variables affecting the responses, according to the 3D response surface graphs. A new accurate and precise RP-HPLC approach has been developed and validated and used to regularly analyse OLM and ATS. HIGHLIGHTS A new, quick, and cost-effective RP-HPLC method for the simultaneous estimation of Atorvastatin Calcium and Olmesartan Medoxomil in bulk and pharmaceutical dosage forms RP-HPLC method developed by experimental design and response surface method Developed method was validated as per ICH guidelines GRAPHICAL ABSTRACT

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Development and validation of rp-hplc method for the estimation of acyclovir in API and tablet formulation

Cited by 2 publications

References 0 publications

New Stability Indicating RP-HPLC Method for Estimation of the Drug Molnupiravir

New Stability Indicating RP-HPLC Method for Estimation of the Drug Molnupiravir

Response Surface Method for the Simultaneous Estimation of Atorvastatin and Olmesartan

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