International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use (1996) Guidelines on Validation of Analytical Procedure Methodology, Geneva, Switzerland.

has been cited by the following article:

• TITLE: Simultaneous Determination of N-Acetyl Cysteine and Taurine by HPTLC Method in Active Pharmaceutical Ingredient and Pharmaceutical Dosage Form

  AUTHORS: A. R. Magesh, Magharla Dasaratha Dhanaraju

  KEYWORDS: High Performance Thin Layer Chromatography, N-Acetyl Cysteine, Taurine, Validation

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.8 No.11, November 14, 2017

  ABSTRACT: Specific, precise and sensitive TLC-Densitometric method was developed and validated for the simultaneous estimation of N-Acetyl cysteine and Taurine in active pharmaceutical ingredient and pharmaceutical dosage form. An effective separation was achieved on pre-coated silica gel HPTLC plates by using n-butanol:acetic acid:water (8:0.5:1.5 v/v/v). The spots were scanned densitometrically at 295 nm. The RF values of N-Acetyl cysteine and Taurine were found to be 0.29 and 0.52, respectively. Calibration curves were linear in the range of 30 - 180 and 100 - 600 ng/band for N-Acetyl cysteine and Taurine, correspondingly with correlation coefficients of 0.999. The developed method was validated as per ICH guidelines. The limits of detection were 11.24 and 63.40 ng/spot for NAC and TAU respectively. The method developed was found to be precise and specific for the simultaneous analysis of N-Acetyl cysteine and Taurine in pure and tablet dosage form.