ABSTRACT
Abstract: The study describes method development and subsequent validation of HPTLCmethod for simultaneous estimation of paracetamol (PCM), diclofenac sodium (DCL) anddicyclomine hydrochloride (DICY) in marketed combined tablet dosage form. The drugs wereextracted from marketed tablet dosage form: Spasmodart. The separation was carried out onaluminium sheet precoated with silica gel 60 F254 using toluene: ethylacetate: methanol: formicacid (5.5:3.5:2:0.02, v/v/v/v) as a mobile phase. The spots were scanned densitometrically at266 nm wavelength for paracetamol and diclofenac sodium. The plate was then dipped in panisaldehyde reagent and spots of dicyclomine hydrochloride were scanned at 638 nmwavelength. The Rf values of paracetamol, diclofenac sodium and dicyclomine hydrochloridewere found to be 0.41, 0.71and 0.24 respectively. Calibration curves were linear in range of3250-9750ng/spot, 500-1500ng/spot and 200-600ng/spot for PCM, DCL and DICY respectively.The limit of detection (LOD) for paracetamol, diclofenac sodium and dicyclomine hydrochloridewere found to be 812.5, 125 and 50ng/spot respectively. The suitability of this method forquantitative determination of compounds was proved by validation in accordance with ICHGuidelines. Therefore this method can be applied for routine analysis of these drugs in tabletformulation.
ABSTRACT
Authors describe a case of angioedema in a male child due to over-the-counter (OTC) use of fixed dose combination (FDC) of Tab. dicyclomine hydrochloride (20mg) and paracetamol (500mg) for abdominal pain. Use of OTC drugs in children without a doctor抯 suggestion can lead to unnecessary medication use and is not free of risks. Here, there is a probable causal relationship between the suspected drug and angioedema according to WHO-UMC criteria for Causality Assessment. This case was also reported to the Pharmacovigilance Programme of India (PvPI) through PvPI ADR android application.