Author(s): D. D. Masne, R. D. Chakole, M. S. Charde

Email(s): manojudps@rediffmail.com

DOI: 10.52711/2231-5675.2022.00006   

Address: D. D. Masne, R. D. Chakole, M. S. Charde*
Post Graduate Department of Pharmaceutical Chemistry, Government College of Pharmacy, Vidyanagar, Karad, Dist.: Satara, Pin - 415124, Maharashtra, India.
*Corresponding Author

Published In:   Volume - 12,      Issue - 1,     Year - 2022


ABSTRACT:
The aim of present research work was to develop simple, precise and rapid RP-HPLC method for analysis of Aripiprazole in tablet dosage form using QbD Method. RP-HPLC method was developed for the estimation of Aripiprazole in tablet dosage form with the help of QbD approaches. The proposed methods were applied for the determination of drug in tablet dosage form. In this method concentration of each drug was obtained by using the absorptivity values calculated for drug wavelength 254nm and solving the equation. A rapid and reliable RP-HPLC method was developed and validated estimation of Aripiprazole in tablet dosage form. The RP-HPLC method was performed C18 (100mm x 4.6 mm,)2.5 µm particle size in gradient mode, and the sample was analyzed using methanol 80 ml and 20 ml (pH 3.3 0.05% OPA with TEA) as a mobile phase at a flow rate of 0.7 ml/min and detection at nm. By the retention time for Aripiprazole found 3.29 min respectively. The method was applied to marketed tablet formulations. The tablet assay was performed for combination was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines. Validation related the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots by both HPLC were linear over the 10-50µg/ml for Aripiprazole respectively, and recoveries from tablet dosage form were between 99.48 and 100.02 %. The method can be used for routine of the quality control in pharmaceuticals. The RP-HPLC method was found to be simple, economical and rapid as compared to MS method was found to be more accurate, precise and robust. Both these methods can be used for routine analysis of Aripiprazole in tablet dosage form.


Cite this article:
D. D. Masne, R. D. Chakole, M. S. Charde. QbD Approached in Method Development, Validation and Degradation Profiling of Aripiprazole a Antidepressent Agent. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):29-4. doi: 10.52711/2231-5675.2022.00006

Cite(Electronic):
D. D. Masne, R. D. Chakole, M. S. Charde. QbD Approached in Method Development, Validation and Degradation Profiling of Aripiprazole a Antidepressent Agent. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):29-4. doi: 10.52711/2231-5675.2022.00006   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-1-6


REFERENCES:
1.    Marchand D. H., Snyder L. R., and Dolan J. W. S.L. : Journal of Chromatography A, 2008, vol. 1191.
2.    Bk., Sharma. Instrumental Methods of Chemical Analysis. S.l.: meerut: Goel Publishing House, 2000. 7.
3.    Gurdeep R. Chatwal, Sham K. Anand. Instrumental Methods of Chemical Analysis. New Dehli: New Delhi: Himalaya Publishing House, 2008. 5.
4.    Gandhi Noopurk, Shahdarshil B, Maheshwari Dilip G 2016 “Aripiprazole and clozapine: A review of spectroscopic and chromatographic method” Asian Journal of Pharmaceutical Technology and Innovation 5 (22) 27-39
5.    Mallikarjuna Rao, Nagasarapu and Gowrisankar Dannana, 2017, New stability indicating high performance liquid chromatography method for the estimation of Aripiprazole in bulk and their formulation. Indian Journal of Drugs 5 (3), 116-123 ISSN: 2348-1684.
6.    Gennaro A.R., Remington. The Sciences and Practice of Pharmacy. Baltimore, Maryland, USA : Luppincott, Williams and Wilkins, 2000.
7.    Douglas AS., Holler FJ., Crouch SR. Principle of Instrumental Analysis, 6th ed, Thomson Publication, 2007: p.1.
8.    Ahmed Naved, Shaikhobaid, Barrawazaateka, Khan Sarfarazzaheer. Zahid 2017 development and validation of rapid HPLC method for determination of aripirazole in bulk drug and pharmaceutical formulation. Journal of Innovations in Pharmaceutical and Biological Science ISSN : 2349-2759 vol 4 (3) 15-19
9.    Sharma BK., Instrumental Methods of Chemical Analysis, 23rd ed, Goel Publishing House, Meerut, 2002: p.7-8.
10.    https://en.wikipedia.org/wiki/Analytical_chemistry
11.    Skoog DA, West DM, Holler FJ. Analytical chemistry – An Introduction, 6th ed. Saunder College Publishing. p.3.
12.    Qbd Approach to Analytical RPHPLC. Devesh A. Bhatt, Smita I. Rane., Dhule : International Journal of Pharmacy and Pharmaceutical Sciences, 2011, Vol. 3. ISSN 0975-1491
13.    Willard HH, Merit LL, Dean JA, Settle FA. Instrumental Methods of Analysis.7thed. New Delhi: CBS Publishers and Distributors; 1996.p.513.
14.    Gurdeep R. Chatwal, Sham K. Anand. Instrumental Methods of Chemical Analysis. New Dehli : Himalaya Publishing House, 2008. 5.
15.    Beckett AH, Stenlake JB.Practical Pharmaceutical Chemistry. New Delhi : CBS Publishers and Distributors, 2002.
16.    Kasture AV, Wadodkar SG, Mahadik KR, More HM. A Textbook of Pharmaceutical Analysis. 10th ed. Vol. II. Pune: Nirali Prakashan; 2004.p.4.


Recomonded Articles:

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): Sushil D. Patil, Sayali K. Chaure, Maswood Ahmed Hafizur Rahman, Prajkta U. Varpe, Sanjay Kshirsagar.

DOI: 10.5958/2231-5675.2017.00004.7         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): Pinaz A. Kasad, K.S. Muralikrishna

DOI:         Access: Open Access Read More

Author(s): Yogita R. Indalkar, Aloorkar N.H.

DOI: 10.5958/2231-5675.2015.00028.9         Access: Open Access Read More

Author(s): Santosh Gada, Anand Kumar Y, Saritha, C. Mallikarjuna Setty

DOI: 10.5958/2231-5675.2018.00036.4         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): B. Thangabalan, M. Salomi, N. Sunitha, S. Manohar Babu

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

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

DOI:         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 

Popular Articles


Recent Articles




Tags