HPLC method validation and Forced degradation study of Paracetamol in bulk and formulation
*1Hemant Deore, 2Ansari Yaasir Ahmed, 3V.L. Badgujar, 4Syed Abdul Azeem, 5 Tabrej Mujawar, 6 Rajesh A. Ahirrao, 7 Surti Sehjad, 8 Ramiz Khan, 9 Sayyad Sajauddin and 10 Anwar Ahmad
1Department of Pharmacology, DCS’s A. R. A. College of Pharmacy, Nagaon, Dhule: 424005 {India} 2Department of Pharm. Chemistry, Ali Allana College of Pharmacy, Akkalkuwa, Dist Nandurbar: 425415 {India} 3Department of Pharm.Chemistry, DCS’s A. R. A. College of Pharmacy, Dhule: 424005 {India} 4Department of Pharmaceutics, Shivlingeshwar College of Pharmacy, Ausa, Dist-Latur-413520 {India} 5Department of Pharmacology, Gangamai College of Pharmacy, Dhule: 424005 {India} 6P.G. College of Pharmaceutical Sciences & Research, Chaupale, Dist: Nandurbar: 425411 {India} 7Department of Pharm. Analysis, School of Pharmacy, Parul University, Vadodara: 391760 {India} 8Department of Pharmaceutics, Ali Allana College of Pharmacy, Akkalkuwa, Dist-Nandurbar: 425415 {India} 9Dayanand College of Pharmacy, a/p Dist-Latur: 413512 {India} 10Department of Pharmaceutics, Central India College of Pharmacy, Nagpur: 441111 {India} Corresponding Author: Hemant Deore, Dept. of Pharmacology, DCS’s A. R. A. College of Pharmacy, Nagaon, Dhule: 424005 {India}
ABSTRACT
To validate HPLC method for determination of Paracetamol in Bulk and formulation. The chromatograms were developed using a mobile phase of MeOH: OPA {35:65} with a flow rate of 1 ml/min. C18 Column of 4.6 x 250 mm dimension was used as a stationary phase, particle size 10µm. The detection was carried out at 286 nm wavelength. The method was validated according to ICH guidelines for linearity, accuracy, precision, LOD, LOQ and robustness. The response was found to be linear in concentration range of 62.5-312.5 mcg/ml for Paracetamol. The LOD and LOQ were found to be respectively 3.3625 and 10.1896 respectively for Paracetamol. The developed method was simple, precise, accurate and therefore suitable for routine analysis of drugs in tablet dosage form.