Abstract
Objective: The proposed method describes method development and validation of nebivolol hydrochloride and cilnidipine in combined pharmaceutical tablet dosage form by high-performance thin-layer chromatography (HPTLC) having adequate specificity, sensitivity, and reproducibility.
 Methods: Nebivolol hydrochloride and cilnidipine drug combination is used for the treatment of hypertension. Precoated aluminum plates with silica gel 60 F254 (E-Merck, Germany) were used for the chromatographic separation which was carried using chloroform:glacial acetic acid:methanol, in 8.5:1:0.5 (v/v/v) as a mobile phase. HPTLC separation of two drugs was carried by densitometric measurement at 270 nm.
 Reults: The drugs were satisfactorily resolved with retardation factor values of 0.0.29±0.008 and 0.69±0.007 for nebivolol hydrochloride and cilnidipine, respectively. The method was found to be linear in the range of 100–1000 ng/spot and 50–500 ng/spot for nebivolol hydrochloride and cilnidipine, respectively. The correlation coefficient was found to be 0.989 and 0.996 for nebivolol hydrochloride and cilnidipine, respectively. Limit of detection and limit of quantitation values were 16.395 ng/band and 49.681 ng/band and 31.788ng/band and 96.328 ng/band, respectively. The mean recovery was found to be 100.570–101.936 and 100.269–101.333 for nebivolol hydrochloride and cilnidipine, respectively. The intra- and inter-day precision was found to be within the limit.
 Conclusion: A simple, accurate, precise, and sensitive HPTLC method has been developed and validated in combined pharmaceutical tablet dosage form for simultaneous estimation of nebivolol hydrochloride and cilnidipine.
Highlights
Hypertension is a disease characterized by abnormal elevation of blood pressure (BP) in the arteries
About 90–95% of cases are termed as primary hypertension, which refers to high BP for which no exact cause can be found
Linearity for nebivolol hydrochloride and cilnidipine was found in the range of 100–1000 ng/band and 50–500 ng/band and regression coefficient (r2) = 0.989 and 0.986, respectively
Summary
Hypertension is a disease characterized by abnormal elevation of blood pressure (BP) in the arteries. It is broadly classified as primary and secondary. About 90–95% of cases are termed as primary (idiopathic) hypertension, which refers to high BP for which no exact cause can be found. Prevention and control of high BP are the main focuses for reducing the severity of cardiovascular diseases [1]. Combination of drugs such as nebivolol HCl and cilnidipine has been prescribed to manage hypertension [2]. Nebivolol HCl (1RS,1′RS)-1,1′-[(2RS,2′SR)-bis(6-fluoro-3,4-dihydro-2H-1benzopyran-2-yl)]- 2,2′-iminodiethanol hydrochloride [3] is a highly selective β1-blocker with nitric oxide-mediated vasodilatory actions and beneficial effects on vascular endothelial function
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