C. Damle Mrinalini 1*, G. Bothara Kailash 2, S. Topagi Kirti 1
- Department of Chemistry, A.I.S.S.M.S. College of Pharmacy, Kennedy Road, R.T.O. Pune-411044, India
- SVKM's NMIMS University's School of Pharmacy and Technology Management, Babulde, Bank of Tapi River, Near Tapi Bridge, Mumbai-Agra Road, Shirpur-425405 (M.S.), India
Abstract
An accurate, sensitive, rapid and precise HPTLC method for analysis of Nebivolol Hydrochloride and Valsartan in the combination has been developed and validated. Literature survey reveals few stability indicating methods for Nebivolol Hydrochloride and Valsartan as single drugs. There is no stability indicating method reported for these two drugs in combination. By use of HPTLC technique, an optimum separation was achieved on plates precoated with silica gel 60 F254 with mobile phase consisting of Ethyl Acetate:Methanol:Acetic acid. Detection and quantization was performed at 280nm and 240nm for Nebivolol Hydrochloride and Valsartan respectively. Method was validated according to the ICH guidelines. The validation parameters checked were specificity, linearity, accuracy, precision, LOD, LOQ. The drugs were subjected to stress conditions like hydrolysis under acidic, basic and neutral conditions, oxidation, heat and photolysis. The degradation products resulting from stress conditions did not interfere with the detection of drug peak. This method can be used for stability monitoring of these drugs.
