ISSN

0974-4150 (Online)
0974-4169 (Print)


Author(s): Chavan Pooja Ajit, Shelar Reshma Dattatraya, Shelake Pallavi Ramchandra, Avinash Mahadeo Bhagwat, Ajit Bhiva Ekal

Email(s): chavanp978@mail.com , reshmadshelar10@gmail , pallavishelakestr@gmail

DOI: 10.52711/0974-4150.2021.00065   

Address: Chavan Pooja Ajit1, Shelar Reshma Dattatraya1, Shelake Pallavi Ramchandra1, Avinash Mahadeo Bhagwat1, Dr. Ajit Bhiva Ekal2
1YSPM’s Yashoda Technical Campus, Faculty of Pharmacy (B. Pharm), Satara.
2Managing Director, Insta Vision Laboratory and Service, Satara.
*Corresponding Author

Published In:   Volume - 14,      Issue - 5,     Year - 2021


ABSTRACT:
Tadalafil is a phosphodiesterase 5 inhibitor accustomed to treat dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension. Tadalafil is an orally administered drug and it's marketed worldwide under the name Cialis. Analytical method development and validation play important roles within the discovery development and manufacture of pharmaceuticals. These methods is to make sure the identity, purity, potency, and performance of drug product. The bulk of the analytical development effort goes into validating a stability indicating HPLC–method. Analytical method development could be a process of proving that the developed chromatography method is suitable for its intended use within the development and manufacturing of the pharmaceutical drug substance and drug product. All analytical methods that are intended to be used for analyzing any clinical samples will have to be validated. The target of the strategy validation is to demonstrate that the strategy is suitable for its intended purpose because it is stated in ICH guidelines.


Cite this article:
Chavan Pooja Ajit, Shelar Reshma Dattatraya, Shelake Pallavi Ramchandra, Avinash Mahadeo Bhagwat, Ajit Bhiva Ekal. RP-HPLC Method Development and Validation of Tadalafil in Tablet Dosage form. Asian Journal of Research in Chemistry. 2021; 14(5):380-8. doi: 10.52711/0974-4150.2021.00065

Cite(Electronic):
Chavan Pooja Ajit, Shelar Reshma Dattatraya, Shelake Pallavi Ramchandra, Avinash Mahadeo Bhagwat, Ajit Bhiva Ekal. RP-HPLC Method Development and Validation of Tadalafil in Tablet Dosage form. Asian Journal of Research in Chemistry. 2021; 14(5):380-8. doi: 10.52711/0974-4150.2021.00065   Available on: https://ajrconline.org/AbstractView.aspx?PID=2021-14-5-14


REFERENCES:
1.    Eli Lilly Nederland BV. Cialis-epar- scientific discussion. European Medicine Agency.2005
2.    John A. Noviasky, Asif Masood, Vincent Lo. Tadalafil (Cialis) for Erectile Dysfunction. American Family Physician. 2014 Jul. 15. Volume: 70. Issue: 2. Page No.359- 360
3.    Tadalafil. Wikipedia. Chemistry of Tadalafil
4.    Saroj Kumar Raut, B.V.V. Ravi Kumar, Ajaya Kumar Pattnaik. A RP- HPLC method development and validation for the estimation of Tadalafil bulk and pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology.2012. Volume: 5. Issue: 2. Page No.1573- 1576
5.    Aziz Unnisa, Yogesh Babu, Santosh Kumar, Siva Chaitanya. RP-HPLC-PDA method development and validation for the analysis of tadalafil in bulk, pharmaceutical dosage form and in-vitro dissolution samples. Journal of Applied Pharmaceutical Science. Vol.4 (12)12. Dec, 2014.

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