Volume : 11, Issue : 12, December – 2024
Title:
DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF NIACIN AND LOVASTATIN IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC
Authors :
Jadhav Pallavi Bhagwan, N.Shravya, P.Aravindra Reddy
Abstract :
A simple specific, sensitive, precise reverse phase high performance liquid chromatography method has been developed for simultaneous estimation of lovastatin and niacin. The determination was carried out by using Symmetry C18 (4.6 x 250mm, 5µm) column with the mobile phase containing acetonitrile: phosphate buffer (pH 4) in the ratio of 65:35 v/v. The optimized flow rate was 0.7ml/min and the UV detection was carried out at 240 nm. The retention time of lovastatin and niacin were found to be 3.093 min and 6.196 min respectively. The method was found to be linear in the concentration range 2.0-10µg/ml for lovastatin and niacin respectively. The method was validated as per ICH guidelines. The proposed method was successfully applied for the estimation of lovastatin and niacin in pharmaceutical dosage forms.
Key words: Lovastatin, Niacin, HPLC, ICH guidelines.
Cite This Article:
Please cite this article in press N.Shravya et al ., Development And Validation For Simultaneous Determination Of Niacin And Lovastatin In Bulk And Pharmaceutical Dosage Form By Rp-Hplc.,Indo Am. J. P. Sci, 2024; 11 (12).
Number of Downloads : 10
References:
1. S. Sudheer Kumar, Pritosh Pattnaik, Arabinda Patnaik, K.V. Subrahmanyam. Method Development and Validation of RP-HPLC Method in The Detection of Lovastatin in Bulk Drug and Capsule Formulation. International Journal of Medicine and Nanotechnology. 2014; 1(3):127-132.
2. R. Vasanthi, J. Prasad, M. Alagar Raja, V. Prashanthi, V. Shrisha, David Banji, D. Selva Kumar. Analytical Method Development and Validation of Lovastatin and Niacin by Using RP-HPLC Method. Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 2015; 3(3):128-136.
3. Jeyashanthini Nalaiya, Sreenivasa Rao Sagineedu, Rajakumari Rajasingam, Zawahil Kassim, Mallikarjuna Rao Pichika, A Stability-Indicating RP-HPLC Method For Simultaneous Determination of Simvastatin and Niacin in a Combined Dosage Form, International Journal of Pharmacy and Pharmaceutical Sciences, Vol 7, Issue 2, 2015, 262-268.
4. Dewani AP, D. S. Mohale, S. Hiware, R. L. Bakal, A. V. Chandewar, Mohd. Salimuddin Farooqui, Development and Validation Of RP-HPLC Method For Simultaneous Estimation of Niacin and Simvastatin in Tablet Dosage. Indian Journal of Pharmacy and Pharmacology, January – March, Vol. 2(1), 2015, 21-26.
5. M. K. Ranganath and Raja Ram Chowdary, Simultaneous Estimation and Validation of Niacin and Atorvastatin Calcium by UV-Spectroscopy in Pure and Tablet Dosage Form Using Methanol: Water Mixture as Solvent. J Pharm Sci | Vol 4 | Issue 2 | Apr–June, 2014,71.
6. Silva TD, Oliveira MA, de Oliveira RB, Vianna-Soares CD. Development and validation of a simple and fast HPLC method for determination of lovastatin, pravastatin and simvastatin. J Chromatogr Sci. 2012 Oct;50(9):831-8.
7. Konda Shravan Kumar, Duddagi Suchitra, Pavan Kumar Kasu, Sukanya Mandala, Chalavadi Sudha Bhargavi, Narender Boggula. RP-HPLC method for simultaneous estimation of trifluridine and tipiracil in pure and tablet dosage form. Biochem. Cell. Arch. 2024; 24(2):2519-2524.
8. Duddagi Suchitra, Konda Shravan Kumar, Chalavadi Sudha Bhargavi, Racha Spandana, Puli Ramya Krishna, Narender Boggula. Determination of darunavir and cobicistat simultaneously using RP-HPLC in bulk and dosage form. Biochem. Cell. Arch. 2024; 24(2):2381-2389.
9. Katkade, P. N. and Saudagar, R. B. Validated UV- Spectroscopic estimation of Simvastatin Concentration in Bulk and Dosage form. Asian J. Res. Chem. 2016; 9: 293–295.
10. Akula, G., Venkatesh, B., Sanjayraj, K., Phanindra, S. S. and Jaswanth, A. Validated RP-HPLC Method for the Simultaneous Estimation of Simvastatin and Niacin. Asian J. Res. Chem. 2016; 9: 62–66.
11. Prabhakar M, Vamshi RM, Shirisha RN, Neha B, Venkateswara RP, Akiful HM, Vasudha B, Narender B. Development and Validation of UV Spectrophotometric Method for The Determination of Bisoprolol in Bulk Material and In Tablets. International Journal of Biology, Pharmacy and Allied Sciences. 2022; 12(6):2822-2834.
12. Ladke, A., Ingle, A., Ranaware, P. and Damle, M. Development and validation of stability indicating HPLC method for Rosuvastatin calcium and Fenofibrate in combination. Asian J. Res. Chem. 2012; 5: 606–610.
13. Chaitanya Kallu, Nikhil Raj Dachaboina, Mohammed Sayeed, Naveen Pathakala, Aravinda Nalla, Jithendar Reddy Mandhadi, Sandeep Bolla, Narender Boggula. Development and Validation for Determination of Apremilast in Bulk and in Tablets by UV Spectrophotometer. Asian Journal of Pharmaceutics. 2024; 18(3):841-847.
14. Urban, M. C. C., Mainardes, R. M. and Gremião, M. P. D. Development and validation of HPLC method for analysis of dexamethasone acetate in microemulsions. Braz. J. Pharm. Sci. 2009; 45: 87–92.
15. Ananda Kumar Chettupalli, Vivek Kunduru, Narender Boggula, Vasudha Bakshi. Development and Validation of Capecitabine Tablet (Pharmaceutical Dosage Form) By Using RP-HPLC Method. Indo Am. J. P. Sci. 2017; 4(03):550-557.
16. Jayaseelan S, Suresh S, Sathishkumar G, Perumal VS. Bio analytical method development and validation lamivudine by RP-HPLC method. Int J Chem Tech Res 2001; 2:163-7.
17. Boggula N, Bhadru B, More K. RP-HPLC Method Validation for Levomilnacipran Estimation in Bulk and Formulation. International Journal of Pharmaceutical Quality Assurance. 2023; 14(4):900-903.