Author(s): Vanita P. Rode, Madhukar R. Tajne

Email(s): vanitaashtankar10@gmail.com

DOI: 10.5958/2231-5675.2018.00009.1   

Address: Vanita P. Rode*, Madhukar R. Tajne
Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur-440 033 (MS) India
*Corresponding Author

Published In:   Volume - 8,      Issue - 1,     Year - 2018


ABSTRACT:
The objective of the present research work is developing a simple, precise, and accurate stability-indicating normal-phase HPTLC method for estimation of Pitavastatin in the bulk drug and tablet formulation. Chromatography was performed on the plates precoated with silica gel 60F254 using toluene: methanol 8:2 (v/v) as a mobile phase. Densitometric quantification was performed at 245 nm by reflectance scanning. The retardation factor of Pitavastatin was 0.50 ± 0.02. Validation of the method in accordance with ICH guidelines yielded good results for range, linearity, precision, accuracy, specificity and robustness. The data of linear regression analysis indicated a good linear relationship over the range of 50– 400 ng/band concentrations with correlation coefficient 0.997. The limits of detection and quantitation were found to be 1.05 and 3.21 resp. Results from analysis of a commercial tablet formulation was 99.12 ± 1.58%. The method precision for the determination of assay was below 2.0 %RSD. The percentage recoveries of active pharmaceutical ingredient (API) from dosage forms ranged from 99.27% to 101.87%. Stress testing of Pitavastatin was carried out according to the international conference of harmonization (ICH) guideline Q1A (R2). The drug was subjected to acid, base, neutral hydrolysis, oxidation, thermal degradation and photolysis which enabled separation and detection of degradation products from acidic, basic, neutral and oxidation stress. No degradation products were obtained after photo and dry heat stress condition.


Cite this article:
Vanita P. Rode, Madhukar R. Tajne. A Validated Stability-Indicating High-Performance Thin-Layer Chromatographic Method for the Analysis of Pitavastatin in Bulk Drug and Tablet Fomulation. Asian J. Pharm. Ana. 2018; 8(1): 49-52. doi: 10.5958/2231-5675.2018.00009.1

Cite(Electronic):
Vanita P. Rode, Madhukar R. Tajne. A Validated Stability-Indicating High-Performance Thin-Layer Chromatographic Method for the Analysis of Pitavastatin in Bulk Drug and Tablet Fomulation. Asian J. Pharm. Ana. 2018; 8(1): 49-52. doi: 10.5958/2231-5675.2018.00009.1   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2018-8-1-9


Recomonded Articles:

Author(s): Dipti G. Phadtare, Pawar Amol R, R.B. Saudagar

DOI: 10.5958/2231-5675.2016.00019.3         Access: Closed Access Read More

Author(s): Sushil D. Patil, Sunil V. Amurutkar, C.D. Upasani

DOI: 10.5958/2231-5675.2016.00030.2         Access: Open Access Read More

Author(s): K. Pramod, Shahid H. Ansari, Javed Ali

DOI:         Access: Open Access Read More

Author(s): G. Krishnamoorthy, C. Diana Priyadarshini, R. Senthamarai

DOI:         Access: Open Access Read More

Author(s): Hamid Khan, Javed Ali

DOI: 10.5958/2231-5675.2017.00020.5         Access: Open Access Read More

Author(s): Shobha Rani G, Lohita M, Jaya Preethi P, Madhavi R, Sunisitha B, Mounika D

DOI:         Access: Open Access Read More

Author(s): Kirthi A, Shanmugam R, Mohana Lakshmi S , Ashok Kumar CK, Padmini K, Shanti Prathyusha M, Shilpa V

DOI:         Access: Open Access Read More

Author(s): Mansi J. Chaudhari, Suraj R. Chaudhari, Shailesh S. Chalikwar, Atul A. Shirkhedkar

DOI: 10.5958/2231-5675.2018.00008.X         Access: Open Access Read More

Author(s): Sri Lakshmi D, Jane T Jacob, Srinivasa Sastry D, Satyanarayana D

DOI: 10.5958/2231-5675.2017.00005.9         Access: Open Access Read More

Author(s): Khushboo Patel*, Dhara Patel, Jaya Dwivedi, Priyanka Newal, Dhananjay Meshram

DOI: 10.5958/2231-5675.2017.00039.4         Access: Open Access Read More

Author(s): P. Janaki Pathi, N. Appala Raju, G.Parvathalu

DOI:         Access: Open Access Read More

Author(s): Paras Virani, Rajanit Sojitra, Hasumati Raj, Vineet Jain

DOI: 10.5958/2231-5675.2015.00025.3         Access: Open Access Read More

Asian Journal of Pharmaceutical Analysis (AJPA) is an international, peer-reviewed journal, devoted to pharmaceutical analysis...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5675 


Recent Articles




Tags