Stability-Indicating HPTLC Method for Estimation of Guaifenesin in Bulk and in Pharmaceutical Formulation
Jain PS*, Kale NK and Surana SJ
RC Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur Dist, Dhule 425 405 (MS) India
- *Corresponding Author:
- Pritam Jain
RC Patel Institute of Pharmaceutical
Education and Research, Karwand Naka
Shirpur Dist, Dhule 425 405 (MS) India
Tel: +02563 255189
Fax: +02563 251808
E-mail: [email protected]
Received date: February 22, 2015; Accepted date: May 23, 2015; Published date: May 30, 2015
Citation: Jain PS, Kale NK, Surana SJ (2015) Stability-Indicating HPTLC Method for Estimation of Guaifenesin in Bulk and in Pharmaceutical Formulation. J Chromatogr Sep Tech 6:273. doi:10.4172/2157-7064.1000273
Copyright: © 2015 Jain PS, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
A HPTLC/ Densitometric method has been developed for the determination of Guaifenesin (GFN) in bulk and pharmaceutical formulation. The estimation of drug was performed on HPTLC aluminium plates precoated with silica gel 60 RP-18 TLC F254 S using toluene: methanol: ethyl acetate: acetic acid (7:0.8:1.2:0.5 v/v/v/v) as mobile phase. The densitometric quantification for the drug was carried out at 274 nm. GFN obeyed linearity in concentration range 800 – 2800 ng/band with coefficient of correlation 0.999. The Rf for GFN was found to be 0.6 ± 0.02. The proposed method was applied for pharmaceutical formulation and % label claim for GFN was found to be 100.34 ± 1.06. The method was validated for accuracy, precision and ruggedness. Accuracy of the method was checked by recovery studies at three different levels i.e. 80 %, 100 % and 120 %. The % recovery of GFN was found to be in the range of 99.48% - 100.68 %; the % RSD value was less than 2 indicates the accuracy of the method. The method was found to be precise as indicated by the inter-day, intra-day and repeatability analysis; showing % RSD less than 2. The results did not show any statistical difference between operators showing that developed method was rugged. GFN was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acid-base conditions, hydrolysis, oxidation, photo degradation except dry heat degradation. This indicates that the drug is susceptible to acid and base. The degraded product was well resolved from the pure drug with significantly different Rf value. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for the identification and quantitative determination of GFN in bulk drug and pharmaceutical formulation.