Abstract
Pharmaceutical analysis plays a very significant role in quality control of pharmaceutical products through a rigid check on raw materials, in process samples, and finished products. It is instrumental in ensuring the quality of pharmaceutical products and requires development of methods with high degree of accuracy and precision. The accuracy and precision depend upon the relative and absolute errors. Errors will be minimized if the method is simple. Thus simplicity of the method can be indirectly related to accuracy and precision. Therefore it is one of the prime considerations while developing analytical method. Literature survey revealed that as such no HPLC method has yet been reported for simultaneous estimation of the drugs selected for the present study (32–92). The drugs include ambroxol hydrochloride, cetirizine hydrochloride, chlorpheniramine maleate, guaiphenesin, paracetamol, phenylephrine hydrochloride, and salbutamol sulfate. The nonavailability of HPLC method for the analysis of the combination of abovementioned drugs made it worthwhile to pursue the present research work. The objective of the present work was to develop simple, accurate, precise, and rapid stability indicating analytical methods for simultaneous estimation of the selected drugs in marketed dosage forms. The developed method was also validated as per ICH guidelines. Assay validation assures the accuracy and reliability of test results for drug identity, strength, quality, and purity. A validated analytical method is often employed for product testing at various critical stages of a manufacturing to check and ensure whether the manufacturing process does what it purports to do.
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Maithani, M., Bansal, P. (2019). Research Envisaged. In: Development of Novel Stability Indicating Methods Using Liquid Chromatography. Springer, Singapore. https://doi.org/10.1007/978-981-13-8723-4_2
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DOI: https://doi.org/10.1007/978-981-13-8723-4_2
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Publisher Name: Springer, Singapore
Print ISBN: 978-981-13-8722-7
Online ISBN: 978-981-13-8723-4
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