Research Journal of Pharmaceutical Dosage Form and Technology

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


Affiliations
1 Department of Pharmaceutical Chemistry, Telangana University, Nizamabad – 503322, India
2 Department of Pharmaceutics, Acharya Nagarjuna University, Nagarjuna Nagar- 522 510, India
3 Department of Pharmaceutics and Pharmaceutical Analysis, Hindu College of Pharmacy, Guntur -522002, India
4 Department of Pharmaceutics, Shadan College of Pharmacy, Hyderabad, Andhra Pradesh -500008, India
     

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A simple, precise, accurate and new stability-indicating reversed-phase high-performance liquid chromatographic (RPHPLC) 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.
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  • ICH Guideline Practice- A Validated Stability- Indicating HPLC Method for the Determination of Efavirenz in Dosage Form

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Authors

T. Gopi Raju
Department of Pharmaceutical Chemistry, Telangana University, Nizamabad – 503322, India
M. Gayatri Ramya
Department of Pharmaceutics, Acharya Nagarjuna University, Nagarjuna Nagar- 522 510, India
A. Rajesh
Department of Pharmaceutics and Pharmaceutical Analysis, Hindu College of Pharmacy, Guntur -522002, India
S. Kathirvel
Department of Pharmaceutics and Pharmaceutical Analysis, Hindu College of Pharmacy, Guntur -522002, India
Sanjay Kumar Gupta
Department of Pharmaceutics, Shadan College of Pharmacy, Hyderabad, Andhra Pradesh -500008, India

Abstract


A simple, precise, accurate and new stability-indicating reversed-phase high-performance liquid chromatographic (RPHPLC) 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.