Dhanavath Mamata, Srinu Naik Sapavatu, KSK Rao Patnaik
Dhanavath Mamata1*, Srinu Naik Sapavatu2, KSK Rao Patnaik2
1Department of Pharmacy, University College of Technology, Osmania University, Hyderabad, Telangana, India, 500007.
2Department of Chemical Engineering, University College of Technology, Osmania University, Hyderabad, Telangana, India, 500007.
Volume - 14,
Issue - 2,
Year - 2021
New HPLC method have been developed for simultaneous analysis of Glecaprevir/Pibrentasvir in pharmaceutical dosage form and applied to portray the in-vitro dissolution profiles of drug product. The title analytes were eluted rapidly with 2.5% sodium taurocholate in phosphate buffer, pH 4.5 and methanol (80:20 v/v) on Kromosil C18 Column (250 x 4.6 mm, 5µ). The detection was carried out using PDA detector at 254 nm. The solutions were chromatographed at a constant flow rate of 1 ml/min. Method was validated as ICH guidelines. The linearity range of Glecaprevir and Pibrentasvir were found to be 10-300 mg/ml and 4-120 mg/ml, respectively. Low % RSD values in precision studies indicates the reproducibility of method. The percentage recovery varies 98-102%, found to be within the limits. The proposed validated method was fruitfully applied for the assay, stability and in-vitro dissolution studies of marketed dosage forms containing Glecaprevir and Pibrentasvir.
Cite this article:
Dhanavath Mamata, Srinu Naik Sapavatu, KSK Rao Patnaik. Stability-indicating HPLC method for simultaneous estimation of Glecaprevir and Pibrentasvir, application to in-vitro Dissolution studies. Research J. Pharm. and Tech. 2021; 14(2):617-622. doi: 10.5958/0974-360X.2021.00110.4
1. Mamidi SVS, Atmakuri LR and Mamidipalli WC. Stability-indicating high-performance liquid chromatographic method for simultaneous assay of pibrentasvir and glecaprevir: method development, validation and application to tablet dosage forms. Journal of Research in Pharmacy. 2019; 23(3): 465-475.
2. Narendra RY, Sreeramulu J and Balaswami B. A new stability- indicating RP-HPLC- PDA method for simultaneous estimation of glecaprevir and pibrentasvir in tablet dosage form. Research Journal of Pharmacy and Technology.2019; 12 (2): 625-631.
3. Sunitha N, Bhargav S, Subash C et al. Method development and validation of glecaprevir and pibrentasvir in pure and pharmaceutical dosage forms by RP-HPLC method. Indian Journal of Research in Pharmacy and Biotechnology. 2019; 7(2): 67-83.
4. Narayanaswamy H, Vijaya VPM, Subramanian G et al. Stability indicating RP-HPLC method development and validation for the simultaneous estimation of pibrentasvir and glecaprevir in bulk and pharmaceutical dosage form. International Journal of Research in Pharmaceutical Sciences. 2019; 10(3):1841-1846.
5. Saroja J, Anantha LPV, Rammohan Y et al. Quantification of antiviral drug combination, glecaprevir and pibrentasvir, in bulk and tablet formulation by stability indicating RP-HPLC method. The Pharma Innovation Journal. 2019; 8(1): 163-169.
6. Sangameshwar BK, Sanjay ST and Debarshi KM. Development of validated stability indicating RP-HPLC method for the estimation of glecaprevir and pibrentasvir in bulk and pharmaceutical dosage form. Journal of Applied Pharmaceutical Sciences. 2019; 9(6): 52-60.
7. Srilatha K, Anjali B, Shweta B et al. Stability indicating RP-HPLC method for simultaneous determination of glecaprevir and pibrentasvir in bulk and pharmaceutical dosage form. World Journal of Pharmaceutical Research. 2019; 8(2): 844-851.
8. Sreeram V and Venkateswarlu. Stability indicating RP-HPLC method for the simultaneous estimation of glecaprevir and pibrentasvir in drug product. Journal of Pharmaceutical Sciences and Research. 2018; 10(11): 2757-2161.
9. Babu DC, Chetty CM and Mastanamma SK. A new force indicating RP-HPLC method development and validation for the simultaneous estimation of pibrentasvir and glecaprevir in bulk and its tablet dosage form. Pharmaceutical Methods. 2018; 9: 79-86.
10. Rama KK, and Raja S. Simultaneous assay of two antiviral agents, pibrentasvir and glecaprevir using stability indicating RP-HPLC method in bulk and tablets. Der Pharmacia Lettre. 2018; 10 (8): 33-47.
11. Saradhi NDVR, Rakesh KJ and Venkata RM. A new technical method for glecaprevir and pibrentasvir in combined dosage forms using non polar HPLC. World Journal of Pharmaceutical and Medical Research. 2018; 4(12): 173-178.
12. Hemalatha K, Kistayya C, Nizamuddhin ND et al. Simultaneous estimation of new analytical method development and validation of glecaprevir and pibrentasvir by high performance liquid chromatography. International Journal of Medical and Pharmaceutical Sciences. 2018; 3(s1), 5-8.
13. Markanda S, Rao TS and Challa GN. Development and validation for the simultaneous estimation of glecaprevir and pibrentasvir in drug product by UPLC. European Journal of Biomedical and Pharmaceutical Sciences. 2018; 5(4): 473-480.
14. Sri DVVSSNR, Manikandan A and Venkat RS. Validation of Simple Isocratic RP-UPLC Method for Glecaprevir and Pibrentasvir determination and its Application in the Study of Stress Degradation. Research Journal of Pharmacy and Technology. 2019; 12(9): 4299-4304.
15. Jagjitsingh CG, Venkateshwarlu G and Saurabh KB. Development and Validation of RP-HPLC Method for Simultaneous Determination of Ceftriaxone Sodium and Sulbactam Sodium in Bulk and Pharmaceutical Formulation. Asian Journal of Research in Chemistry. 2009; 2(3): 280-284.
16. Venkatachalam, Narendiran S, Kalai SP et al. RP-HPLC Method for Simultaneous Determination of Ofloxacin and Satranidazole in Tablet Dosage Form. Asian Journal of Research in Chemistry. 2009; 2(4): 469-471.
17. Syama SB and Balamuralikrishna K. Development and Validation of New Reversed Phase High Performance Liquid Chromatography Method for the Estimation of Efavirenz in Bulk and in Pharmaceutical Dosage Forms. Asian Journal of Research in Chemistry. 2011; 4(4): 555-557.
18. Soumya K, Susanna S, Murthy TEGK. In vitro Dissolution Studies on Commercial Brands Containing Immediate Release Pioglitazone and Metformin Hydrochloride Extended Release Tablets. Research Journal of Pharmaceutical Dosage Forms and Technology. 2017; 9(1): 15-18.
19. Srinivasa RJ. Naga M, M. Sri MS et al. Comparative in Vitro Dissolution Assessment of Three Different Brands of Lansoprazole Capsules. Research Journal of Pharmaceutical Dosage Forms and Technology. 2011; 3(2): 58-66.
20. Saravanakumar A, Sunita M, Madhulika P et al. Polylactic Acid Microspheres as A Potential Vaccine Delivery System for the Tetanus Toxoid: Preparation and In Vitro Dissolution Study. Research Journal of Pharmacy and Technology. 2008; 1(4): 453-459.
21. Vijaya CS. Effect of Ammonium Compounds as Additives on the Dissolution Rate of Limestone Samples Sourced from Tirunelveli District, Tamil Nadu, India. Asian Journal of Research in Chemistry. 2010; 3(4): 990-994.
22. Atul HK, Dhaval MP, Bhushan PI et al. Spectrophotometric and Stability Indicating RP-HPLC-PDA method for Simultaneous Determination of Finasteride and Tamsulosin in Combined Tablet Dosage form. Asian Journal of Research in Chemistry. 2009; 2(4): 414-419.