Volume No. :   6

Issue No. :  1

Year :  2014

ISSN Print :  0975-234X

ISSN Online :  0975-4377


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ICH Guideline Practice- a Validated Stability- Indicating HPLC Method for the Determination of Efavirenz in Dosage Form.



Address:   T. Gopi Raju2, M. Gayatri Ramya1*, A. Rajesh3, S. Kathirvel3, Sanjay Kumar Gupta4 1Department of Pharmaceutics, Acharya Nagarjuna University, Nagarjuna Nagar- 522 510,
2Department of Pharmaceutical Chemistry, Telangana University, Nizamabad – 503322,
3Department of Pharmaceutics and Pharmaceutical Analysis, Hindu College of Pharmacy, Guntur -522002,
4Department of Pharmaceutics, Shadan College of Pharmacy, Hyderabad, Andhra Pradesh -500008
*Corresponding Author
DOI No:

ABSTRACT:
A simple, precise, accurate and new stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated as per International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines to determine efafirenz in tablet dosage form. The drug was successfully eluted at 6.264 min by mixture of ammonium dihydrogen phosphate buffer, acetonitrile and triethylamine (30:70:1) on C18 column (150 mm × 4.6 mm, 5 µm) at the flow of 1.5 ml/min. Drug content was determined in between 99.79% and 100.33% with standard deviation of 0.217. The validated RP-HPLC method may be successfully applied for assay, dissolution studies, bio-equivalence studies, as well as routine analysis in pharmaceutical industries.
KEYWORDS:
RP-HPLC, Efavirenz, ICH.
Cite:
T. Gopi Raju, M. Gayatri Ramya, A. Rajesh, S. Kathirvel, Sanjay Kumar Gupta. ICH Guideline Practice- a Validated Stability- Indicating HPLC Method for the Determination of Efavirenz in Dosage Form. Res. J. Pharm. Dosage Form. & Tech. 6(1): Jan.-Mar. 2014; Page 07-14.
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