Author(s):
Priya R. Wani, Vikram Jadhav, Ashish Jain, Vaishali Jadhav
Email(s):
priyawani703@gmail.com , pharmavikram17@gmail.com , drashishjain80@gmail.com , vaishalikudekar@gmail.com
DOI:
10.52711/2231-5675.2024.00022
Address:
Priya R. Wani1, Vikram Jadhav2, Ashish Jain3, Vaishali Jadhav4*
1,4Department of Quality Assurance, Shri D. D. Vispute College of Pharmacy and Research Center, Devad, Vichumbe, Gut No.104, Adjacent to Mumbai-Pune Express Highway, Tal. Panvel, Dist. Raigad, Maharashtra, India 410 221.
2Mini Drugs Testing Laboratory, Office of the ADC(I), Central Drugs Standard Control Organization, M/s JWR Logistic Pvt ltd 15-45, National Highway 4B, Panvel - JNPT Highway, Village Padeghar, Post - Vahal, Panvel - Maharashtra, India 410206.
3Department of Pharmacognosy and Phytochemistry, Shri D. D. Vispute College of Pharmacy and Research Center, Devad, Vichumbe, Gut No.104, Adjacent to Mumbai - Pune Express Highway, Tal. Panvel, Dist. Raigad, Maharashtra, India 410 221.
*Corresponding Author
Published In:
Volume - 14,
Issue - 3,
Year - 2024
ABSTRACT:
UV spectrophotometry was performed by Lab India Analytical UV 3092 using methanol as medium. The resolution process was performed in the range of 200–400nm to determine the maximum absorption (? max). The ?max of Nirmatrelvir was found to be 210nm. Measure the absorbance of 10, 20, 30, 40, 50, and 60µg/ml drug solution and measure the maximum absorbance at 210 nm with a blank control. Then draw a graph from the concentration on the X-axis and the absorbance on the Y-axis to get a straight line. Validation parameters such as linearity, precision, specificity, LOD and LOQ, accuracy and robustness were evaluated according to ICH guidelines.
Cite this article:
Priya R. Wani, Vikram Jadhav, Ashish Jain, Vaishali Jadhav. UV Spectrophotometric Method Development and Validation for the Determination of Nirmatrelvir Antiviral Drug in Bulk and its In-house Formulation. Asian Journal of Pharmaceutical Analysis. 2024; 14(3):127-0. doi: 10.52711/2231-5675.2024.00022
Cite(Electronic):
Priya R. Wani, Vikram Jadhav, Ashish Jain, Vaishali Jadhav. UV Spectrophotometric Method Development and Validation for the Determination of Nirmatrelvir Antiviral Drug in Bulk and its In-house Formulation. Asian Journal of Pharmaceutical Analysis. 2024; 14(3):127-0. doi: 10.52711/2231-5675.2024.00022 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2024-14-3-3
REFERENCES:
1. Lu J. Nirmatrelvir: a first-in-class CDK4/CDK6 inhibitor for the treatment of hormone-receptor positive advanced breast cancer. Journal of Hematology and Oncology. 2015; 8(1):98.
2. Ma X, Liu L, Cao N, Zou Q, Xiong K, Ouyang P. Isolation and Structural Elucidation of Nirmatrelvir's Eight Process-Related Impurities: Two Identified as New Compounds. Journal of AOAC International. 2016; 99(3):638-648.
3. Dange Y, Bhinge S, Salunkhe V. Optimization and validation of RP-HPLC method for simultaneous estimation of Nirmatrelvir and Letrozole. Toxicology Mechanisms and Methods. 2018; 28(3):187-194.
4. Nalanda R, Rao AS, Sankar DG. Determination of Nirmatrelvir In Human Plasma Using High Performance Liquid Chromatography-Ultraviolet Detection. International Journal Of Pharmaceutical Sciences And Research. 2018; 9(9):3883-3888.
5. Al-Shehri M, Hefnawy M, Abuelizz H, Alzamil A, Mohammed M, Alsaif N. Development and validation of an UHPLC-MS/MS method for simultaneous determination of Nirmatrelvir, letrozole and its metabolite carbinol in rat plasma and pharmacokinetic study application. Arabian Journal of Chemistry. 2020; 13(2): 4024-4034.
6. Tamane PK, Pai RG, Pokharkar VB. A simple, rapid and sensitive high-performance thin-layer chromatographic method for the simultaneous estimation of berberine and 5-fluorouracil in rabbit plasma. JPC – Journal of Planar Chromatography – Modern TLC. 2020 DOI: https://doi.org/10.1007/s00764-020-00013-4
7. Gaikwad S, Bansode A, Patade N, Tathe S. Stability-indicating HPTLC method development for determination of arterolane maleate and piperaquine phosphate in combined dosage form. JPC–Journal of Planar Chromatography–Modern TLC. 2020. DOI: https://doi.org/10.1007/s00764-020-00021-4
8. Yeniceli Uğur D, Uğur A. Analysis of anticancer drugs using thin layer chromatography-A review. Marmara Pharmaceutical Journal. 2018; 22(3):334-346.
9. Sonia K, Lakshmi K. HPTLC Method Development and Validation: An Overview. Journal of Pharmaceutical Sciences and Research. 2017; 9(5):652-657.
10. Nirmatrelvir. Paxlovid 150 mg/100 mg film-coated tablets - Summary of Product Characteristics (SmPC). 2022- (emc) (medicines.org.uk)
11. ICH, Q2B. ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization, 2005.
12. Ayya Rajendra Prasad, Bannaravuri Thireesha. UV spectrophotometric method development and validation for the determination of Lornoxicamin microsponges. International Journal of Applied Pharmaceutics, 2017.
13. J. Nagamallika, Aruna Mahesh. Development and Validation of Spectrophotometric Method for the Estimation of Aripiprazole in Tablet Dosage Form. Asian J. Pharm. Ana. . 2011; 1(3): 46-49.
14. Sonali D. Rathod, P.M. Patil, S. B. Jadhav , P.D. Chaudhari. UV Spectrophotometric Simultaneous Determination of Metformine Hydrochloride and Pioglitazone Hydrochloride in Combined Dosage Form. Asian J. Pharm. Ana. 2012; 2(1): 5-9.
15. UV- Spectrophotometric Method Development and Validation for Estimation of Tizanidine and ceclofenac in Tablet Formulation. Asian J. Pharm. Ana. 2012; 2(4): 101-103.
16. S. Rawat, Akhilesh Gupta. Spectrophotometric Method for Simultaneous Estimation of Nimesulide and Diclofenac Sodium in Pharmaceutical Dosage Forms. Asian J. Pharm. Ana. 2011; 1(4): 85-87.
17. B. Siddartha, I. Sudheer Babu, A. Krupalini, Prathyusha V. Development and Validation of UV– Spectrophotometric Method of Tolterodine in bulk and harmaceutical Dosage Form. Asian J. Pharm. Ana. 2013; 3(3): 102-104.
18. Humera Pathan, Shrikrishna Baokar, Undare Santosh, Patil R.N. Estimation of Venlafaxine in Commercial Dosage Forms Using Simple and Convenient Spectrophotometric Method. Asian J. Pharm. Ana. 2015; 5(3): 142-146.
19. N. Vanaja, Ch. Preethi, S.Y. Manjunath, Krishanu Pal. Method Development and Validation for Simultaneous Estimation of Telmisartan and Ramipril by UV-Spectrophotometric Method in Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2015;5(4): 187-194.
20. Saroj Kumar Raul, Gopal Krishna Padhy, Pramudula Ramya Krishna, Boddu Uma Madhu Priya. UV Spectrophotometric Method Development and Validation for the Estimation of Valsartan in Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2016; 6(3): 147-150.
21. Saroj Kumar Raul, Bukkuru Spandana, Patibandla Sameera, Vegiraju Vikitha. UV Spectrophotometric Method Development and Validation for the Estimation of Gliclazide in Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2016; 6(3): 143-146.
22. K. Vijaya Sri, S. Sravani, M. Shiva Kumar. Development and Validation of UV Spectrophotometric Method for Estimation of Lurasidone in Bulk and Pharmaceutical Formulations. Asian J. Pharm. Res. 2015; 5(2): 102-107.
23. Zainab A. Bagalkote, Ganesh Gajeli. UV Spectrophotometric Method Development and Validation of Carbimazole in Bulk and Tablet Dosage form. Asian Journal of Pharmaceutical Research. 2021; 11(3): 163-6.