A simple and precise stability indicating method for the simultaneous estimation of dapagliflozin and saxagliptin in combined tablet dosage form was developed and validated using RP-HPLC.

A simple and precise novel stability-indicating method for the simultaneous estimation of tezacaftor and ivacaftor in combined tablet dosage form was developed and validated using reversed-phase high-performance liquid chromatography (RP-HPLC). The method is being reported for the first time and includes an estimation of degradation products produced post-stress conditions without any extraction or derivatization. The chromatographic separation of the drugs was achieved with a Symmetry Shield RP18 Column (100 Å, 5 μm, 4.6 mm × 250 mm) using a mixture of buffer, methanol and acetonitrile (42:27:31 v/v/v) as mobile phase. The buffer used in mobile phase contained 35 mM potassium dihydrogen phosphate, and its pH was adjusted to 7.0 ± 0.02 with 20% orthophosphoric acid. The instrument was set at flow rate of 1.2 mL min−1 at ambient temperature and the wavelength of UV-visible detector at 275 nm. The developed method could be suitable for the quantitative determination of these drugs in pharmaceutical preparations and also for quality control in bulk manufacturing. Stress testing was performed to prove the specificity. No interference was observed from its stress degradation products. The statistical analysis was done by using F-test and t-test at 95% confidence level.

The present study was aimed to formulate and evaluate floating tablets of indomethacin by wet granulation method. Indomethacin is used as a potent anti-inflammatory drug with prompt anti pyretic action, mainly used for the treatment of osteoarthritis with half-life of 4.5 hrs. Indomethacin is stable in neutral or slightly acidic media. In this study, excipients like HPMC 5cps, sodium bi carbonate were incorporated in a nine different concentrations (F1-F9) along with other excipients (PVP K30, lactose, talc, and magnesium stearate) to formulate floating tablets by wet granulation method. Then all the nine formulations were evaluated for uniformity of weight, hardness, thickness, friability test, floating lag time, drug content, dissolution studies and stability studies. The dissolution profile of trial-6 (formulation 6) was observed to be better than other formulations. In trial-6 indomethacin was formulated as a floating tablet by using HPMC 5cps (120 mg) as a matrix forming polymer and sodium bi carbonate (40 mg) as a gas generating agent. Trial-6 formulation showed a good dissolution profile for a controlled period of time which was noticed to be as 97.78 % at the end of 12 th hour. Thus, it can be concluded that the floating drug delivery system of indomethacin using the appropriate polymers in right amount may enhance the activity of the drug by prolonging the gastric residence time or reducing the floating lag time.

Stability studies must be carried out according to the guidelines provided by the International Conference of Harmonization, World Health Organization, and other agencies in a scheduled manner. The pharmaceutical product’s stability can be defined as the ability, within its physical, chemical, microbiological, toxicology, protective, and informational requirements of a particular formulation in a specific container-closure system. It also guarantees that the performance, safety, and efficacy are maintained throughout the shelf life of any pharmaceutical product which is considered as pre-requisite for acceptance and approval. Different stability test methods have originated with the need for constant monitoring of drugs and products for their quality and purity. In this review, we have included the types of stability of drugs substances, the relevance of different methods used to test the stability of the pharmaceutical product, guidelines issued to test the stability of pharmaceuticals, stability testing protocols which describes the main components of a well-controlled and regulated stability test and other aspects of stability.

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