Developing a Stability Indicating Ultra Performance Liquid Chromatographic Method for Simultaneous Quantitation of Degradation Products of Telmisartan and Hydrochlorothiazide in Combination Dosage Form | Chapter 3 | Advanced Concepts in Pharmaceutical Research Vol. 9

 

Telmisartan (TLM) is an angiotensin receptor blocker (ARB) that has an extensive period of working and has the lengthy half-life of any ARB. Telmisartan works by blocking a substance in the body that causes blood vessels to tighten. This work is intended to thrive a stability-indicating Ultra performance liquid chromatographic method for the estimation of Telmisatam (TLM) and Hydrochlorothiazide (HCTZ) and degradation products pharmaceutical dosage forms. Separation was carried out on Zorbax Eclipse XDB C-18(50 x mm, 1.7 µm) column using a gradient method. Mobile phase A is 10mM KH2PO4 having 1% (v/v) of trimethylamine and mobile phase B is acetonitrile used in this work. 0.5 mL/ minute is the flow rate and at 271 nm noticed wavelength is monitored. Method development trails were carried out on six different columns. For specificity, limit of quantification, limit of detection, linearity, accuracy, method precision, robustness and stability this method is validated. The correlation coefficient of the impurities is more than 0.99. The stability indicating method confirmed that there was no interference of all impurities of TLM and HCTZ. TLM and HCTZ tablet samples stored and long-term storage conditions. The effect of storage conditions results proved that the method has stability indicating capability. Hence, the developed LC method was stability indicating and well applied for drug product stability study as well as for quality monitoring.

Author(s) Details:

Narasimha Reddy G. P,
Department of Chemistry, Sri Krihnadevaraya University Anantapur, Anantapuramu, Andhra Pradesh, India.

 

Sreenivasulu Reddy T.
Department of Chemistry, Sri Krihnadevaraya University Anantapur, Anantapuramu, Andhra Pradesh, India.


Sidda Reddy K.
Department of Chemistry, Sri Krihnadevaraya University Anantapur, Anantapuramu, Andhra Pradesh, India.

Shashi Kumar K. N.
Department of H&S, Annamacharya Institute of Technology & Sciences, Kadapa, 516003, Andhra Pradesh, India.


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Study on Development and Validation of Stability Indicating RP-HPLC Method for Guaifenesin | Chapter 1 | Technological Innovation in Pharmaceutical Research Vol. 11

 A simple, accurate, and exact stability indicating RP HPLC technique was developed and validated for the determination of Guaifenesin in bulk and formulation. Under various forced degradation settings, the drug and its breakdown products were separated on a Phenomenex C18 column (250 4.6 mm, 5) using a mobile phase of methanol:water (60:40 percent v/v). The flow rate was kept constant at 1.0 mL/min and the eluents were detected at 230 nm. In forced degradation testing, guaifenesin deteriorated in acid, alkali, photolytic, and wet heat environments, but remained stable in H2O2 (oxidative) and dry heat environments. In calibration curve investigations, linearity was discovered in the concentration range of 2-12 g/mL, with a regression coefficient (R2) of 0.999. y = 102800 x + 24264 was the equation found. For the determination of guaifenesin, a rapid, simple, sensitive, and accurate HPLC –UV approach has been described. It may be deduced from the forced degradation investigations that guaifenesin is degraded by acid, alkali, moist heat, and photolysis.

Author (S) Details

Sandhya R. Gawai
Department of Quality Assurance, MET Institute of Pharmacy, Nasik, Maharashtra, India.

Kiran Gadge
Department of Quality Assurance, MET Institute of Pharmacy, Nasik, Maharashtra, India.

Sandeep Sonwane
Department of Quality Assurance, MET Institute of Pharmacy, Nasik, Maharashtra, India.

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