Author(s): Kiran Kumar Buralla, Varadarajan Parthasarathy

Email(s): kirankumarburalla@gmail.com , vapartha@yahoo.com

DOI: 10.5958/0974-360X.2020.00861.6   

Address: Kiran Kumar Buralla, Varadarajan Parthasarathy*
Department of Pharmacy, Annamalai University, Annamalainagar - 608002, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 10,     Year - 2020


ABSTRACT:
Objective: Development of an accurate, precise, robust, sensitive, economical and rapid isocratic reverse phase high performance liquid chromatography (RP-HPLC) technique complying quality by design (QbD) and validate according to ICH guidelines for the quantitative estimation of Paclitaxel in bulk and pharmaceutical dosage form. Method: The simultaneous assessment of the Paclitaxel with Nilotanib as internal standard in bulk and pharmaceutical dosage forms with the help of chemometrics, multicriteria decision-making approach. The separation was achieved by utilizing Phenomenex Enable C18 column (Gemini, 15x4.6mm, 5µm particle size) and PDA-UV detection set at 230nm was developed and validation of Paclitaxel in pure form and pharmaceutical formulation, optimized by Derringer’s desirability functions. Chromatographic separation was consisted of a mixture of acetonitrile and KH2PO4 (70:30 %v/v, pH 4) adjusted with orthophosphoric acid and the flow rate of 0.8ml/min. Result: Newly developed method resulted in eluting the drug at 3.928min, respectively. The regression coefficients (R2) were observed to be 0.999 for all models. The detection of limits (LOD) was about 9.498ng/ml and quantitation limits (LOQ) were about 31.66ng/ml. The relative standard deviation was observed to be 1.842%. Peak area ratio of the analyte and internal standard was used for the estimation of pharmaceutical formulations. Conclusion: The method was validated by determining its precision, accuracy, and system stability. The results of the investigation demonstrated that the suggested RP-HPLC method is simple, rapid, precise and accurate, which is convenient for the routine determination of Paclitaxel in bulk and pharmaceutical dosage forms.


Cite this article:
Kiran Kumar Buralla, Varadarajan Parthasarathy. Central Composite Design based Development and Validation of an RP-HPLC Method for Paclitaxel in Bulk and Pharmaceutical Dosage Form. Research J. Pharm. and Tech. 2020; 13(10):4895-4902. doi: 10.5958/0974-360X.2020.00861.6


REFERENCES:
1.    Peltier S, Oger JM, Lagarace F, Couet W, and Benoit JP. Enhanced oral paclitaxel bioavailability after administration of paclitaxel-loaded lipid nanocapsules. Pharmaceutical Research. 2006; 23(6): 1243-50.
2.    ICH Stability testing: photostability testing new drug substances and products international conference on Harmonization, IFPMA, Geneva. (1996).
3.    Chang AE, Ganz PA, Hayes DF, Kinsella T, Pass HI, Schiller JH, and Stone RM. Victor oncology: An Evidence-Based Approach. Springer Science and Business Media.2007; 34.
4.    Kim SC, Yu J, Lee JW, Park ES, Chi SC Sensitive HPLC method for quantitation of paclitaxel (Genexol®) in biological samples with application to preclinical pharmacokinetics and biodistribution. J Pharm Biomed Anal. 2005; 39: 170- 176.
5.    Ciutaru D, Badea I, Lazar L, Nicolescu D, and Tudose A. A HPLC validated assay of paclitaxel’s related impurities in pharmaceutical forms containing Cremophor EL. J Pharm Biomed Anal. 2004; 34: 493-499.
6.    Zhang SQ, Song YN, He XH, Zhong BH, and Zhang ZQ. Liquid chromatography-tandem mass spectrometry for the determination of paclitaxel in rat plasma after intravenous administration of poly (L-glutamic acid)-alanine-paclitaxel conjugate. J Pharm Biomed Anal. 2010; 51: 1169-1174.
7.    Rajender G, and Narayan NGB. Liquid Chromatography–Tandem Mass Spectrometry Method for Determination of Paclitaxel in Human Plasma. Pharmaceutica Analytica Acta. 2010; 1:101.
8.    Guideline IHT. Validation of analytical procedures: text and methodology. Q2 (R1) 2005:1.
9.    Montgomery D. Design and analysis of experiment” New York, John Wiley and Sons (1991).
10.    Shiow-Ling L, and Wen-Chang C. Optimization of medium composition for the production of glycosyltransferase by Aspergillus niger with response surface methodology. Enz. Microb. Technol.1997; 21:436.
11.    Myers RH, and Montgomery DC. Response Surface Methodology: Process and Product Optimization Using Designed Experiments, 2nd ed. Wiley, New York (2002).
12.    Ferreira SL, Bruns RE, Ferreira HS, Matos GD, David JM, Brandao GC, da-Silva EG, Portugal LA, dos-Reis PD, Souza AS, and dos Santos WN. Box-Behnken design: an alternative for the optimization of analytical methods. Anal. Chim. Acta. 2007; 597:179.
13.    International Conference on Harmonization. ICH Q2 (R1)., (2005). Validation of analytical procedures: text and methodology, ICH Secretariat, Geneva.
14.    Bhatt DA, and Rane SI. QbD approach to analytical RP- HPLC method development and its validation. Int. J. Pharm. Pharm. Sci. 2011; 3: 1179–1187.
15.    Bhutani H, Kurmi M, Singh S, Beg S, and Singh B. Quality by design (QbD) in analytical sciences: an overview, Pharm. Times. 2004; 46: 71–75.
16.    Schmidt AH, Stanic M, and Molnar I. In silico robustness testing of a compendial HPLC purity method by using a multidimensional design space build by chromatography modeling- case study pramipexole. J. Pharm. Biomed. Anal. 2014; 91: 97–107.
17.    Chaudhari SR, and Shirkhedar AA. Design of experiment avenue for development and validation of RP-HPLC-PDA method for determination of apremilast in bulk and in-house tablet formulation, Journal of Analytical Science and Technology. 2019; 10:10.
18.    ICH, ICH Draft Guidelines on Validation of Analytical Procedures: Definition and Terminology, Switzerland, Federal Register, IFPMA (1995).
19.    Ajaz A, Mohammad R, Khalid M.A, Kazi M, and Faiyaz S. Box-Behnken supported development and validation of robust RP-HPLC method: An application in estimation of pravastatin in bulk and pharmaceutical dosage form. 2016; 61(2): 2963-2967.
20.    Padmaja N, and Veerabhadram G. Development and validation of analytical method for Simultaneous estimation of Empagliflozin and Linagliptin in bulk drugs and combined dosage forms using UV-visible spectroscopy. Der Pharmacia Lettre. 2015; 7: 306-312.
21.    Beg S, Kohli K, Swain S, Hasnain M S. Development and validation of RP-HPLC method for quantitation of amoxicillin trihydrate in bulk and pharmaceutical formulations using Box-Behnken experimental design. Journal of Liquid Chromatography and Related Technologies. 2011; 35:393–406.
22.    Barmpalexis P, Kanaze FI, and Georgarakis E. Developing an optimizing a validated isocratic reversed phase HPLC separation of nimodipine and impurities in tablet using experimental design methodology. Journal of Pharmaceutical and Biomedical Analysis. 2009; 49:1192-1202.
23.    Suresh R, Manavalan R, Valliappan K. Chemometrics Assisted RP- HPLC Method for the Simultaneous Determination of Levocetirizine, Ambroxol, and Montelukast in Pharmaceutical Formulation International Journal of Pharmaceutical and Chemical Sciences. 2012; 1:1205-1220.
24.    Sujan B, Masud Kaisar Md, Salim Hossain Md. Development and Validation of a Simple and Rapid UV Spectrophotometer Method for Assay of Linagliptin in Bulk and Marketed Dosage Form. Indian Journal of Novel Drug Delivery. 2013; 5:221-224.
25.    Sara SM, Eman IE, Dalia AH, Magda AB. Stability- Indicating HPLC-DAD Method for the Determination of Linagliptin in Tablet Dosage Form: Application to Degradation Kinetics. Journal of Chromatographic Science. 2016; 54:1560–1566.

Recomonded Articles:

Author(s): Ravindranath S. Misal, Vishawas R. Potphode, Vijay R. Mahajan

DOI: 10.5958/0974-360X.2017.00218.9         Access: Open Access Read More

Author(s): Niharika, Navneet Verma

DOI: 10.5958/0974-360X.2016.00182.7         Access: Open Access Read More

Author(s): A. S. K. Sankar, B. Datchayani, N. Balakumaran, Mohammed Rilwan, R. Subaranjani

DOI: 10.5958/0974-360X.2017.00047.6         Access: Open Access Read More

Author(s): U.S Mahadeva Rao, Khamsah Suryati Mohd, Abdurrazaq Muhammad, Bashir Ado Ahmad, Mohaslinda Mohamad, Rosmawati Mat Ali

DOI: Not Available         Access: Open Access Read More

Author(s): Rekha Rajendran, R Hemachander, T Ezhilarasan, C Keerthana, DL Saroja, KV Saichand, Mohamed Gasim Abdullah

DOI: Not Available         Access: Open Access Read More

Author(s): Vandana Gautam, Dhriti Kapoor, Saroj Arora, Renu Bhardwaj*

DOI: 10.5958/0974-360X.2016.00166.9         Access: Open Access Read More

Author(s): Archana Kushwaha, Jayanti Jaiswal, Priya Singh, Neha Rathore, Jai Prakash Dhruw, Ishu Sahu, Chhaya Singh, Krinsha Kumar Sahu, Mukta Agrawal, D. K. Tripathi, Ajazuddin, Amit Alexander

DOI: 10.5958/0974-360X.2017.00270.0         Access: Open Access Read More

Author(s): Mukta D. Naykode, Durgacharan A. Bhagwat, Swapnil D. Jadhav, Harinath N. More

DOI: 10.5958/0974-360X.2017.00133.0         Access: Open Access Read More

Author(s): Mayanka Singh, Manoj Charde, Rajesh Shukla, Rita M. Charde

DOI: Not Available         Access: Open Access Read More

Author(s): Narendra Chotai, Vishnu Patel, Harsha Patel, Uren Patel, Rajendra Kotadiya

DOI:         Access: Open Access Read More

Author(s): Homendra Kumar Sahu, Kamdev Sen, Raju Patel, Hulash Sahu, Deepika Sahu, Gulshan Sahu, Chandrashekhar Jain, Narayan Prasad Chandra, Mukta Agrawal, D. K. Tripathi, Ajazuddin, Amit Alexander

DOI: 10.5958/0974-360X.2017.00173.1         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags