ABSTRACT:
The validation method of epinastine hydrochloride from combined dosage form i.e. eye drops was described by high performance liquid chromatography method with separation of drugs on Water symmetry RP18 (150 x 4.6 mm i.d.) and 5 µ particle size. A mixture of buffer and acetonitrile (73:27 % (v/v)) was constituted as mobile phase. The chromatograms were studied at 220 nm as wavelength. The mobile phase was also used as a diluent. A validated of method was studied for linear regression, accuracy, method as well as system precision. The robustness study was done for change in wavelength, mobile phase composition and flow rate as per ICH guidelines. The method has been successfully used to analyze epinastine hydrochloride from dosage form i.e. eye drops.
Cite this article:
Rajan V. Rele. Prathamesh P. Tiwatane. Reverse Phase High Performance Liquid Chromatography for Validation of Epinastine Hydrochloride in Bulk and Pharmaceutical Dosage Form. Asian Journal of Research in Chemistry 2023; 16(3):237-0. doi: 10.52711/0974-4150.2023.00039
Cite(Electronic):
Rajan V. Rele. Prathamesh P. Tiwatane. Reverse Phase High Performance Liquid Chromatography for Validation of Epinastine Hydrochloride in Bulk and Pharmaceutical Dosage Form. Asian Journal of Research in Chemistry 2023; 16(3):237-0. doi: 10.52711/0974-4150.2023.00039 Available on: https://www.ajrconline.org/AbstractView.aspx?PID=2023-16-3-9
REFERENCES:
1. Aparajita Malakar, Bishwajit Bokshi. Development and validation of stability indicating RP-HPLC method for the determination of Epinastine Hydrochloride in Pharmaceutical dosage form, International Current Pharmaceutical Journal. 2012;1(3): 50-55.
2. Sai Vkds Kapakayala1, Mubeen G1, Ritu Kimbahune. Reverse phase-high performance liquid chromatographic method for quantitation of Epinastine hydrochloride in eye drops, Indo American Journal of Pharmaceutical Research. 2013; 3(9): 7541-7549.
3. Ahirrao V.K. and Pawar R.P. Stability-Indicating LC Method for the Determination of Epinastine in Bulk Drug and in Pharmaceutical Dosage Form, Research Journal of Recent Sciences. 2012; 1(ISC-2011): 281-288.
4. Milind baburao Ubale, Jagdish v. bharad and Vilas r. Chaudhary. A validated stability-indicating HPLC assay, J. Curr. Chem. Pharm. Sc. 2012; 2(2): 107-112.
5. Ramzia I. El-Bagary, Amal Boshra, Maha M. El-Hakeem, Amira M. Abdelra’oof . Three analytical methods for determination of Epinastine hydrochloride in bulk and in ophthalmic solutions, Journal of Chemical and Pharmaceutical Research. 2012; 4(2):1361-1369.
6. Vkds. Sai, Ritu Kimbahune, Mubeen G, Preeti Karwa, S.Nandini. Application of derivative spectroscopy for quantitative estimation of Epinastine hydrochloride in presence of benzalkonium chloride as preservative in eye drops, International Journal of Biopharmaceutics. 2013; 4(2) : 104-109.
7. K. Harinadha Baba, C. Rambabu, Riyaz Ahmed Khan and K. Anil Kumar, Assay of epinastine in bulk and its pharmaceutical formulations by extractive spectrophotometry, Rasayan Journal of Chemistry. 2014; 7 (4):359 – 364.