DOI: 10.21276/ajptr
Fri, 19 Apr 2019

HPTLC method Development, Validation for Simultaneous Determination of Efavirenz, Emtricitabine and Tenofovir in combined tablet formulation and Forced Degradation Studies


Nikalje Anna Pratima1*, Maniyar Ajhar1, Obaid Shaikh1

1. Y.B. Chavan College of Pharmacy, Dr. Rafiq Zakaria Campus, Rauza Bagh, P.B. No. 33, Aurangabad-431001 (M.S.), India.



A simple, sensitive, accurate and precise high performance thin layer chromatographic method was developed and validated for simultaneous determination of efavirenz (EFA), emtricitabine (EMT) and tenofovir (TEN) in combined tablet formulation and forced degradation studies were performed as per ICH guidelines. Precoated silica gel 60F 254 was used as stationary phase and the mobile phase used was chloroform: methanol (90:10), gives high resolution for each drug. The densitometric evaluation of each drug was carried out at 262 nm. The developed method was simple, accurate and is suitable for analysis of the drugs and degradation products in stability studies of samples.

Keywords: HPTLC; Forced degradation studies; efavirenz (EFA); emtricitabine (EMT); tenofovir (TEN); ICH guidelines.

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