Stability-indicating HPTLC method for simultaneous estimation of Drotaverine and Nimesulide in pharmaceutical dosage form
By Sohan Chitlange, Nitin Kumar, Parag Kulkarni, Sagar Wankhede
The present work describes a stability-indicating HPTLC method for simultaneous analysis of Drotaverine (DRO) and Nimesulide (NIM) in bulk and pharmaceutical dosage form. Precoated silica gel 60 F254 plate was used as stationary phase. The separation was carried out using Cyclohexane: Methanol: Ethyl acetate (6: 2: 2 v/v/v) as mobile phase. The densitometric scanning was carried out at 295 nm. The Rf values was found to be 0.15 for DRO and 0.53 for NIM. The linearity was obtained in the range 100-600ng/band and 200-700ng/band with correlation coefficients (r2 = 0.9945) and (r2 = 0.9957) for DRO and NIM. The method was validated as per ICH guidelines. The drug combination was subjected to forced degradation by acid, alkali, oxidation and dry heat. The degradation products were well resolved from the pure drugs with significantly different Rf values.
Keywords : Drotaverine (DRO); Nimesulide (NIM); HPTLC; Validation; Stability Studies